Cardiac Resynchronization Therapy, Congestive Heart Failure
Conditions
Keywords
cardiac resynchronization therapy; heart failure, congestive
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)
Interventions
DEVICEApplication of quadripolar / bipolar LV electrodes
Sponsors
Heart and Diabetes Center North-Rhine Westfalia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in peak oxygen consumption | 6 months |
| Reduction of New York Heart Association (NYHA) functional class | 6 months |
| Survival | 6 months |
Countries
Germany
Outcome results
None listed