Quartet™ Bad Oeynhausen Trial

Not Applicable

Completed

• Conditions: Cardiac Resynchronization Therapy; Congestive Heart Failure
• Interventions: Device: Application of quadripolar / bipolar LV electrodes

• Registration Number: NCT01850264
• Lead Sponsor: Heart and Diabetes Center North-Rhine Westfalia

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 patients undergoing cardiac resynchronization therapy (CRT)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-19
• Study Start: 2013-03
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-09
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadripolar LV electrode	Application of quadripolar / bipolar LV electrodes	Application of a quadripolar LV electrode
Bipolar LV electrode	Application of quadripolar / bipolar LV electrodes	Application of a bipolar LV electrode

Primary Outcome Measures

Name	Time	Method
Reduction of New York Heart Association (NYHA) functional class	6 months
Increase in peak oxygen consumption	6 months
Survival	6 months

Trial Locations

Locations (1)

Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum; 🇩🇪 Bad Oeynhausen, Germany