Status:
TERMINATED
Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
Lead Sponsor:
Biotronik SE & Co. KG
Collaborating Sponsors:
Biotronik, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 Sen...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 16 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2020
Estimated Enrollment :
2226 Patients enrolled
Trial Details
Trial ID
NCT02290028
Start Date
December 16 2014
End Date
January 23 2020
Last Update
March 24 2021
Active Locations (119)
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1
Fairhope, Alabama, United States
2
Anchorage, Alaska, United States
3
Chula Vista, California, United States
4
Inglewood, California, United States