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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00853593
Registration number
NCT00853593
Ethics application status
Date submitted
26/02/2009
Date registered
2/03/2009
Date last updated
18/02/2019
Titles & IDs
Public title
Model 4396 Left Ventricular (LV) Lead Study
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Scientific title
Model 4396 Left Ventricular Lead Study
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Secondary ID [1]
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116
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Universal Trial Number (UTN)
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Trial acronym
4396
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Pacing Lead
Experimental: Model 4396 LV Lead - Non-randomized study.
Treatment: Devices: Pacing Lead
implant and follow-up of study device
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety (Subjects Without a Model 4396 Lead Related Complication)
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Assessment method [1]
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A subject who was free of a Model 4396 lead related complication by the one month visit. All adverse events (AE) in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee (AEAC). The AEAC determined whether an AE was a complication and whether the event was related to the Model 4396 lead. A complication is an AE that results in death, termination of significant device function or invasive intervention (any therapy that penetrates the skin including administration of intramuscular (IM) and parenteral (IV) fluids).
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Timepoint [1]
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One month
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Primary outcome [2]
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Efficacy: Distal Tip Electrode Voltage Threshold
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Assessment method [2]
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Subjects' distal tip electrode voltage threshold was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts. Voltage threshold was collected using LV tip to Right Ventricular (RV) coil configuration at 0.5 milliseconds [ms]. Voltage threshold is the minimum energy required from the device to consistently pace the ventricle.
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Timepoint [2]
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One month
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Primary outcome [3]
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Efficacy: Proximal Ring Voltage Threshold
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Assessment method [3]
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Subject's proximal ring electrode voltage threshold was collected at the three months visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts.
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Timepoint [3]
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Three months
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Secondary outcome [1]
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Subjects Successfully Implanted With Model 4396 Lead
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Assessment method [1]
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A successful implant occurs when the Model 4396 lead is implanted in a left ventricular vein and functions appropriately. A Model 4396 implant attempt was defined as any time when a Model 4396 lead was introduced into the body.
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Timepoint [1]
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During implant procedure.
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Secondary outcome [2]
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Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation
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Assessment method [2]
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A successful implant after cannulation occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead (any transvenous LV lead) is implanted in a left ventricular vein and functions appropriately. An implant attempt of any transvenous LV lead was defined as any time when a transvenous LV lead was introduced into the body.
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Timepoint [2]
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During implant procedure.
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Secondary outcome [3]
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Subjects Successfully Implanted With Any Transvenous LV Lead
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Assessment method [3]
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A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately.
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Timepoint [3]
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During implant procedure.
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Secondary outcome [4]
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Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead
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Assessment method [4]
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A successful implant occurs when any Medtronic Attain Family LV Lead is implanted in a left ventricular vein and functions appropriately. The Attain Family leads include the following models: 4193, 4194, 4195, 4196, and 4396.
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Timepoint [4]
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During implant procedure.
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Secondary outcome [5]
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Cannulation Time
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Assessment method [5]
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Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation.
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Timepoint [5]
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During implant procedure.
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Secondary outcome [6]
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Fluoroscopy Time
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Assessment method [6]
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The total time the fluoroscope was imaging (not including biplane fluoroscopy time).
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Timepoint [6]
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During implant procedure.
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Secondary outcome [7]
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Model 4396 Lead Placement Time
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Assessment method [7]
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Model 4396 lead placement time was defined as the time from insertion of the successfully implanted lead to the time when it was placed in the first acceptable pacing location.
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Timepoint [7]
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During implant procedure.
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Secondary outcome [8]
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Total Operation Time
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Assessment method [8]
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Total operation time was defined as time from initial incision to final closure.
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Timepoint [8]
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During implant procedure.
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Secondary outcome [9]
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Assessment of Lead Handling Characteristics Reported as Acceptable
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Assessment method [9]
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Implant lead handling characteristics were qualitatively assessed through physician feedback on the Implant Case Report Form (CRF). Physicians were asked for their overall assessment of the lead and results were categorized as acceptable or unacceptable. The number of acceptable responses are summarized.
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Timepoint [9]
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During implant procedure.
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Secondary outcome [10]
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Efficacy: Bipolar Voltage Threshold
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Assessment method [10]
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Subjects' voltage threshold in the bipolar configuration was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold (at 0.5 milliseconds [ms]) is less than or equal to 4.0 Volts.
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Timepoint [10]
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1 month
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Secondary outcome [11]
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Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold
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Assessment method [11]
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Tip electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold values at the 6 month visit are summarized.
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Timepoint [11]
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6 month
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Secondary outcome [12]
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Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance
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Assessment method [12]
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Subjects' tip electrode pacing impedance (a measure of electrical resistance) was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.
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Timepoint [12]
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6 month
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Secondary outcome [13]
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Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing
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Assessment method [13]
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Tip electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here. Sensing is the minimum energy produced by the left ventricle of the heart that the device can sense.
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Timepoint [13]
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6 month
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Secondary outcome [14]
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Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold
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Assessment method [14]
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Ring electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is presented here.
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Timepoint [14]
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6 month
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Secondary outcome [15]
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Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance
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Assessment method [15]
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Subjects' ring electrode pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.
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Timepoint [15]
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6 month
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Secondary outcome [16]
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Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing
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Assessment method [16]
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Ring electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected only at the implant procedure because the devices allowed in this study are not programmable to collect sensing measurements using the ring electrode. The analyzer was used to collect measurements.
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Timepoint [16]
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During implant procedure.
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Secondary outcome [17]
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Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold
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Assessment method [17]
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Bipolar voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is reported here.
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Timepoint [17]
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6 month
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Secondary outcome [18]
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Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance
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Assessment method [18]
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Subjects' bipolar pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.
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Timepoint [18]
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6 month
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Secondary outcome [19]
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Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing
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Assessment method [19]
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Bipolar sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here.
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Timepoint [19]
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6 month
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Eligibility
Key inclusion criteria
- CRT/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications, New York
Heart Association (NYHA) III and IV, indicated for implantable cardiac defibrillator
(ICD) if CRT-D is implanted, patient consent, geographically stable
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- LV lead implant attempt in last 30 days, unstable angina or acute myocardial
infarction (MI) in past 30 days, coronary artery bypass graft (CABG) or percutaneous
transluminal coronary angioplasty (PTCA) in past 3 months, contraindicated for
transvenous pacing, heart transplant
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2010
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Sample size
Target
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Accrual to date
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Final
197
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Bendigo
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Recruitment postcode(s) [1]
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- Bendigo
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Georgia
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Country [4]
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United States of America
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State/province [4]
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Illinois
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Country [5]
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United States of America
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State/province [5]
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Iowa
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Country [6]
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United States of America
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State/province [6]
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Kansas
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Country [7]
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United States of America
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State/province [7]
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Kentucky
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Country [8]
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United States of America
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State/province [8]
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Louisiana
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Country [9]
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United States of America
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State/province [9]
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Minnesota
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Country [10]
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United States of America
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State/province [10]
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New York
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Country [11]
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United States of America
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State/province [11]
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North Carolina
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Country [12]
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United States of America
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State/province [12]
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Oregon
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Country [13]
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United States of America
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State/province [13]
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Pennsylvania
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Country [14]
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United States of America
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State/province [14]
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Tennessee
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Country [15]
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United States of America
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State/province [15]
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Texas
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Country [16]
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United States of America
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State/province [16]
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West Virginia
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Country [17]
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Austria
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State/province [17]
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Linz
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Country [18]
0
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Canada
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State/province [18]
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Alberta
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Country [19]
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Canada
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State/province [19]
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British Columbia
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Country [20]
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Canada
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State/province [20]
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Ontario
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Country [21]
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Canada
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State/province [21]
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Quebec
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Country [22]
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Denmark
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State/province [22]
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Aarhus
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Country [23]
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France
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State/province [23]
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Nantes
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Country [24]
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France
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State/province [24]
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Toulouse
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Country [25]
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Italy
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State/province [25]
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Treviso
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Country [26]
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Saudi Arabia
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State/province [26]
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Riyadh
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Medtronic Cardiac Rhythm and Heart Failure
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is designed to show that a new lead, which paces the left bottom chamber (left
ventricle) of the heart, is safe and effective. Using a lead on the left side of the heart
has been shown to potentially improve heart failure symptoms. The shape and size of this new
lead may make it a good choice for patients or physicians.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00853593
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Derek Exner, MD
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Address
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Foothills Hospital (University of Calgary)
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00853593
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