Clinical Investigation on differences in the magnitude of CRT response in WOmen versus ME
Phase 4
Completed
- Conditions
- Heart Failure: decreased pump function of the heart10019280
- Registration Number
- NL-OMON55752
- Lead Sponsor
- Biotronik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 94
Inclusion Criteria
indication for a de novo implantation of a CRT device according to ESC
Guidelines
written informed consent
Exclusion Criteria
CRT replacements or upgrades
Permanent Atrial Fibrilation
age < 18
NYHA IV
life expectancy less than 12 months
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Information on the heart function and volumes as measured with standard<br /><br>echocardiography: ejection fraction (%EF), volumes etc...</p><br>
- Secondary Outcome Measures
Name Time Method <p>classification of HF status: NYHA I, II, III or IV<br /><br>QOL test: Minesotta Living with Heart Failure Questionaire<br /><br>exercise capacity test: 6 minute hall walk test<br /><br>SAE reporting with focus on HF hospitalization, mortality..<br /><br>composite HF score (modified Packer score)<br /><br>basline ECG (QRS duration and morphology) as predictor for CRT response (males<br /><br>vs females)</p><br>