Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
Query!
Scientific title
Model 4396 Left Ventricular Lead Study
Query!
Secondary ID [1]
0
0
116
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
4396
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Heart Failure
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Safety (Subjects Without a Model 4396 Lead Related Complication)
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
One month
Query!
Primary outcome [2]
0
0
Efficacy: Distal Tip Electrode Voltage Threshold
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
One month
Query!
Primary outcome [3]
0
0
Efficacy: Proximal Ring Voltage Threshold
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Three months
Query!
Secondary outcome [1]
0
0
Subjects Successfully Implanted With Model 4396 Lead
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
During implant procedure.
Query!
Secondary outcome [2]
0
0
Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
During implant procedure.
Query!
Secondary outcome [3]
0
0
Subjects Successfully Implanted With Any Transvenous LV Lead
Query!
Assessment method [3]
0
0
A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately.
Query!
Timepoint [3]
0
0
During implant procedure.
Query!
Secondary outcome [4]
0
0
Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
During implant procedure.
Query!
Secondary outcome [5]
0
0
Cannulation Time
Query!
Assessment method [5]
0
0
Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation.
Query!
Timepoint [5]
0
0
During implant procedure.
Query!
Secondary outcome [6]
0
0
Fluoroscopy Time
Query!
Assessment method [6]
0
0
The total time the fluoroscope was imaging (not including biplane fluoroscopy time).
Query!
Timepoint [6]
0
0
During implant procedure.
Query!
Secondary outcome [7]
0
0
Model 4396 Lead Placement Time
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
During implant procedure.
Query!
Secondary outcome [8]
0
0
Total Operation Time
Query!
Assessment method [8]
0
0
Total operation time was defined as time from initial incision to final closure.
Query!
Timepoint [8]
0
0
During implant procedure.
Query!
Secondary outcome [9]
0
0
Assessment of Lead Handling Characteristics Reported as Acceptable
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
During implant procedure.
Query!
Secondary outcome [10]
0
0
Efficacy: Bipolar Voltage Threshold
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
1 month
Query!
Secondary outcome [11]
0
0
Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
6 month
Query!
Secondary outcome [12]
0
0
Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
6 month
Query!
Secondary outcome [13]
0
0
Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
6 month
Query!
Secondary outcome [14]
0
0
Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
6 month
Query!
Secondary outcome [15]
0
0
Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
6 month
Query!
Secondary outcome [16]
0
0
Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
During implant procedure.
Query!
Secondary outcome [17]
0
0
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold
Query!
Assessment method [17]
0
0
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.
Query!
Timepoint [17]
0
0
6 month
Query!
Secondary outcome [18]
0
0
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
6 month
Query!
Secondary outcome [19]
0
0
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing
Query!
Assessment method [19]
0
0
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.
Query!
Timepoint [19]
0
0
6 month
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/08/2010
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
197
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Bendigo
Query!
Recruitment postcode(s) [1]
0
0
- Bendigo
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Iowa
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kansas
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kentucky
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Minnesota
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New York
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
North Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Oregon
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Pennsylvania
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Tennessee
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Texas
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
West Virginia
Query!
Country [17]
0
0
Austria
Query!
State/province [17]
0
0
Linz
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Alberta
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
British Columbia
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Ontario
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Quebec
Query!
Country [22]
0
0
Denmark
Query!
State/province [22]
0
0
Aarhus
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Nantes
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Toulouse
Query!
Country [25]
0
0
Italy
Query!
State/province [25]
0
0
Treviso
Query!
Country [26]
0
0
Saudi Arabia
Query!
State/province [26]
0
0
Riyadh
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Medtronic Cardiac Rhythm and Heart Failure
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00853593
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Derek Exner, MD
Query!
Address
0
0
Foothills Hospital (University of Calgary)
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00853593
Download to PDF