DRKS00011133
Completed
Phase 4
Impact of right heart function and pulmonary venous Hypertension on CRT Response in patients with left ventricular dysfunction and dyssynchrony - Bivent
niversitätsklinikum Magdeburg0 sites115 target enrollmentJanuary 30, 2017
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- I50
- Sponsor
- niversitätsklinikum Magdeburg
- Enrollment
- 115
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with heart failure symptoms lasting at least 6 weeks (according to the
- •current guidelines for CRT treatment of chronic heart failure)
- •2\. At least 18 years of age
- •3\. Medical need for implants (implants based on the standard implant guidelines
- •from the European Society of Cardiology (ESC))
- •4\. Left ventricular ejection fraction (LVEF) \< 35% as assessed by the investigator
- •5\. NYHA functional status II, III or IV
- •6\. QRS duration \> 130 ms
- •7\. Medical therapy, unless contraindicated, includes
- •\- ACE inhibitor or
Exclusion Criteria
- •1\. Life expectancy \< 12 months
- •2\. Pregnancy (routine test before left and right heart catheter examination)
- •3\. Prior CRT
- •4\. Atrial arrhythmias
- •5\. Right bundle branch block
- •6\. QRS \< 130 ms
- •7\. Heart failure requiring continuous intravenous therapy
- •8\. Patients with acute coronary syndromes or coronary revascularization within 4
- •months before CRT
Outcomes
Primary Outcomes
Not specified
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