Cardiac Resynchronization Therapy in patients with systolic Heart Failure and mechanical dyssynchrony undergoing Coronary Artery Bypass Grafting
Withdrawn
- Conditions
- weakened heart muscleHeart Failure10019280
- Registration Number
- NL-OMON38064
- Lead Sponsor
- Biotronik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
Planned CABG surgery
systolic ischemic heart failure despite pharmacological therapy
Left Ventricular Ejection Fraction <= 35%
NYHA II-IV
Intraventricular mechanical delay > 72 ms (to be confirmed by echo corelab)
Exclusion Criteria
Myocardial viability < 25%
emergency CABG surgery
Age < 18 years
pregnant or brest feeding woman
previous CRT
permanent or persistant atrial arrhytmias
knwon intolerance to contrast agent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of the study is to determine whether an improvement in<br /><br>cardiac function (remodeling of the heart and increase the ejection fraction)<br /><br>can be observed in patients with immediate aplication of CRT after CABG<br /><br>surgery.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints will examine the effect of this immediate treatment<br /><br>with CRT on the quality of life (using a QOL questionnaire), the exercise<br /><br>performance (using the 6 minutes walking test), heart failure symptoms (using<br /><br>the NYHA classification), the number of hospital admissions for heart failure<br /><br>and mortality.</p><br>