Status:
COMPLETED
Quartet™ Bad Oeynhausen Trial
Lead Sponsor:
Heart and Diabetes Center North-Rhine Westfalia
Conditions:
Congestive Heart Failure
Cardiac Resynchronization Therapy
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Primary objective of this study is to evaluate whether the use of a quadripolar left ventricular (LV) electrode compared to a standard bipolar LV electrode leads to lower non-responder rates in patien...
Eligibility Criteria
Inclusion
- Indication for CRT-D implantation according to current guidelines
- Ischemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM)
- Sinus rhythm
- NYHA II-IV
- Age ≥ 18 years
- Written informed consent to participate in the study
Exclusion
- Right bundle brunch block
- Valvular cardiomyopathy
- Patient receiving a non-transvenous LV electrode
- Known pregnancy
- Age \< 18 years
- Life expectancy \< 1 year
- Atrial fibrillation / atrial flutter at the time of enrolment
- Inability to provide informed consent
- Participation in another study with active therapeutic arm
- Regular follow-up in the study center within the first 6 months after implantation not guaranteed
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01850264
Start Date
March 1 2013
End Date
December 1 2018
Last Update
January 30 2019
Active Locations (1)
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1
Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum
Bad Oeynhausen, Germany, 32545