Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders
Phase 2
Completed
- Conditions
- Cardiomyopathy
- Interventions
- Device: Cardiac Resynchronization Therapy Device
- Registration Number
- NCT02247427
- Lead Sponsor
- Yuksek Ihtisas Hospital
- Brief Summary
The purpose of this study is to determine clinical outcomes related to deactivation of Cardiac Resynchronization Therapy device in subjects with super response.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- super response to Cardiac Resynchronization Therapy
- near normal Left ventricular ejection fraction
- >99% pacing
Exclusion Criteria
- <99% pacing
- atrial fibrillation
- ischemic cardiomyopathy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Off-pace group Cardiac Resynchronization Therapy Device Deactivated device group
- Primary Outcome Measures
Name Time Method Clinical/Echocardiographic outcome 12 months Clinical/Echocardiographic outcome including New York Heart Association class, 6-min walk test, Left ventricular ejection fraction, Left ventricular end- diastolic diameter, Left ventricular end-systolic volume, and Left ventricular end-systolic diameter.
- Secondary Outcome Measures
Name Time Method Mortality 12 months Number of participants experiencing mortality
Heart failure hospitalization 12 months Number of participants experiencing heart failure hospitalization
Cardiac Resynchronization Therapy Device intervention 12 months Heart failure hospitalization Cardiac Resynchronization Therapy Device intervention for detected episodes.