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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/NCT02290028
Registration number
NCT02290028
Ethics application status
Date submitted
10/11/2014
Date registered
13/11/2014
Date last updated
24/03/2021
Titles & IDs
Public title
Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
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Scientific title
Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
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Secondary ID [1]
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CR016
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Universal Trial Number (UTN)
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Trial acronym
QP ExCELs
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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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0
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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 - Sentus QP left ventricular lead
Other: Sentus QP left ventricular lead - Subjects consented and implanted with a Sentus QP left ventricular lead.
Treatment: Devices: Sentus QP left ventricular lead
Implantation of quadripolar left ventricular lead in patients with CRT-D indication
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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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Sentus QP Related Complication-free Rate Through 6 Months
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Assessment method [1]
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The purpose of primary endpoint 1 is to evaluate the Sentus QP related complication-free rate through 6 months post-implant. This is evaluated as a percentage of participants without a complication.
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Timepoint [1]
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6 months
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Primary outcome [2]
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Percentage of Participants With Acceptable Pacing Threshold of Sentus QP Lead in Permanently Programmed Vector at 3 Months
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Assessment method [2]
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The purpose of primary endpoint 2 is to evaluate the LV lead pacing threshold for the permanently programmed pacing vector at 3 months post-implant.This was evaluated by performing an exact, binomial test comparing the percentage of participants with acceptable pacing thresholds to a performance goal of 88%. LV threshold values of less than or equal to 2.5 V at 0.4 ms in the permanently programmed vector are considered acceptable.
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Timepoint [2]
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3 months
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Primary outcome [3]
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Sentus QP Related Complication-free Rate
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Assessment method [3]
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The purpose of primary endpoint 3 is to evaluate the Sentus QP related complication-free rate through study termination (post approval phase). This is evaluated as a percentage of participants without a complication.
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Timepoint [3]
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Up to 4 years
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Secondary outcome [1]
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Sentus QP Acceptable Pacing Threshold in Permanently Programmed Vector at 3 Months Per Lead Model
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Assessment method [1]
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The purpose of the secondary endpoint is to evaluate the LV lead pacing threshold for the permanently programmed pacing vector at 3 months post-implantation in the two different lead types, Sentus OTW QP L and Sentus OTW QP S. This was evaluated as the number of participants with an acceptable pacing threshold out of the total number of patients for each lead model. LV threshold values of less than or equal to 2.5 V at 0.4 ms in the permanently programmed vector is considered acceptable.
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Timepoint [1]
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3 months
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Secondary outcome [2]
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Sentus QP Acceptable Pacing Threshold in Novel Vectors at 3 Months
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Assessment method [2]
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The purpose of this secondary endpoint is to evaluate the number of participants with at least one acceptable LV lead pacing threshold in a novel pacing vector at 3 months post-implantation. This was evaluated as the number of participants with at least one acceptable LV pacing threshold in a novel pacing vector out of the total number of participants with completed novel pacing threshold testing. LV threshold values of less than or equal to 2.5 V at 0.4 ms in a novel pacing vector is considered acceptable.
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Timepoint [2]
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3 months
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Secondary outcome [3]
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Sentus QP Acceptable R-wave Sensed Amplitude at 3 Months Per Lead Model
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Assessment method [3]
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The purpose of this secondary endpoint is to evaluate acceptable LV lead sensing amplitude at 3 months post-implantation. This was evaluated as the number of participants with an acceptable LV sensing amplitude out of the total number of participants. R-wave sensed mean amplitude of greater than or equal to 2 mV is considered acceptable.
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Timepoint [3]
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3 months
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Secondary outcome [4]
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Sentus QP Acceptable Pacing Impedance at 3 Months Per Lead Model
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Assessment method [4]
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The purpose of this secondary endpoint is to evaluate the acceptable LV lead pacing impedance at 3 months post-implantation. This was evaluated as the number of participants with an acceptable LV pacing impedance out of the total participants. LV impedance values of greater than 200 Ohms and less than 2000 Ohms is considered acceptable.
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Timepoint [4]
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3 months
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Secondary outcome [5]
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Sentus QP Time to Complication
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Assessment method [5]
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The purpose of this secondary is to evaluate the Sentus related complication-free rate through 6 months post-implant by the Kaplan-Meier method. The below table shows Kaplan-Meier estimates of the estimated freedom from Sentus related complications at 180 days.
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Timepoint [5]
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6 months
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Secondary outcome [6]
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Sentus QP Related Complication-free Rate Per Lead Model
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Assessment method [6]
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The purpose of secondary endpoint 7 is to evaluate the Sentus QP related complication-free rate through study termination (post approval phase). This is evaluated as percentage of participants without a complication per lead model.
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Timepoint [6]
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Up to 4 years
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Secondary outcome [7]
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Individual Sentus QP Adverse Event Rates
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Assessment method [7]
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The purpose of secondary endpoint 8 is to evaluate the rate of individual types of adverse events related to the Sentus QP lead through study termination (post approval phase). This is evaluated as the percentage of participants with a specific adverse event out of the total participants.
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Timepoint [7]
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Up to 4 years
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Secondary outcome [8]
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Number of Participants Successfully Reprogrammed to Resolve Phrenic Nerve Stimulation or High Pacing Threshold
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Assessment method [8]
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The purpose of this secondary endpoint is to evaluate the number of participants in whom phrenic nerve stimulation or high LV pacing threshold was be successfully resolved by reprogramming of the LV pacing vector. This is evaluated as the number of participants with successful reprogramming out of all participants experiencing phrenic nerve stimulation or high LV pacing threshold. LV pacing threshold resulting in invasive intervention, or, in the absence of intervention, a lead threshold that has increased two fold from the chronic threshold value, and is unable to achieve a 2:1 safety margin at follow-up is considered a high LV pacing threshold.
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Timepoint [8]
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12 months
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Eligibility
Key inclusion criteria
- Standard CRT-D indication according to clinical routine
- De novo implantation or upgrade from existing ICD or pacemaker implant utilizing a
BIOTRONIK CRT-D system with IS4 LV port and Sentus QP LV lead
- Patient is able to understand the nature of the clinical investigation and provide
written informed consent
- Patient is able and willing to complete all routine study visits at the
investigational site through 5 years of follow-up
- Patient accepts Home Monitoring® concept
- Age = 18 years
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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
- Chronic atrial fibrillation
- Contraindication to CRT-D therapy
- Currently implanted with an endocardial or epicardial left ventricular lead or had
prior attempt to place a left ventricular lead
- Cardiac surgical procedure, such as coronary artery bypass graft or valve surgery that
is planned to occur within 6 months after implant or ablation that is planned to occur
within 90 days after implant (ablations planned to occur prior to or at implant are
not exclusionary)
- Expected to receive a heart transplant or ventricular assist device within 6 months
- Life expectancy less than 12 months
- Participation in any other investigational cardiac clinical investigation during the
course of the study
- Presence of another life-threatening, underlying illness separate from their cardiac
disorder
- Pregnant or breast-feeding at time of enrollment
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Study design
Purpose of the study
Other
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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
Terminated
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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
16/12/2014
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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
23/01/2020
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Sample size
Target
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Accrual to date
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Final
2226
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Flinders Medical Center - Bedford Park
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Lyell McEwing Hospital - Elizabeth Vale
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The Northern Hospital - Epping
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Royal Hobart Hospital - Hobart
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Nambour General Hospital - Nambour
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Recruitment postcode(s) [1]
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- Bedford Park
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- Elizabeth Vale
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- Epping
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- Hobart
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Recruitment postcode(s) [5]
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- Nambour
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Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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California
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Colorado
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District of Columbia
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Florida
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Louisiana
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Zwickau
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Brescia
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Italy
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Como
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Barcelona
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Madrid
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Luzern
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Switzerland
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Zürich
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biotronik SE & Co. KG
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Biotronik, Inc.
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Ethics approval
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Summary
Brief summary
The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK Sentus OTW QP
left ventricular leads to satisfy FDA requirements for regulatory approval of the leads in
the US. The Sentus OTW QP leads received FDA approval on May 4, 2017.
Long-term safety of the BIOTRONIK Sentus OTW QP left ventricular leads will be confirmed
during the ongoing post approval phase (US sites only).
A protocol update was implemented on September 6, 2019 to transition the long-term follow up
for the ongoing Sentus QP Study to a new EP PASSION real-world data methodology.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02290028
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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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Antonio Curnis, Prof.
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Address
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Spedali Civili - Universita di Brescia, Italy
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02290028
Download to PDF