Quartet™ Bad Oeynhausen Trial

Heart and Diabetes Center North-Rhine Westfalia81 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congestive Heart Failure Cardiac Resynchronization Therapy

Interventions

Application of quadripolar / bipolar LV electrodesDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum

Bad Oeynhausen, Germany

Outcomes

Primary Outcomes

Increase in peak oxygen consumption

Time frame: 6 months

Reduction of New York Heart Association (NYHA) functional class

Time frame: 6 months

Survival

Time frame: 6 months

Data from ClinicalTrials.gov

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