Trial in Cardiac Resynchronization Therapy (CRT): Right Ventricular Apex Versus High Posterior Septum
Phase 2
- Conditions
- Heart Failure
- Interventions
- Device: CRT in heart failure; Right ventricular apex v.s. high posterior septum
- Registration Number
- NCT01035489
- Lead Sponsor
- Haukeland University Hospital
- Brief Summary
In heart failure patients we hypothesised that right ventricular high posterior septum is superior to right ventricular apex in CRT and DDD pacemaker. In two separate trials we prospectively randomized the right ventricular lead placement to find evidence of differences in heart failure symptoms (NYHA-class), 6 minute hall walk and echocardiographic measurements of reverse remodelling and dyssynchrony.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 85
Inclusion Criteria
-
CRT:
- LVEF < 35%
- LVEDD > 5.5 cm
- NYHA 3-4
- QRS > 120 ms
- Optimal medical treatment
- Both CRT-pacemakers (CRT-P) and CRT combined with ICD (CRT-D)
Exclusion Criteria
- Not fulfilling inclusion criteria or not written consensus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CRT; RV apical lead placement CRT in heart failure; Right ventricular apex v.s. high posterior septum Right ventricular apical lead placement in CRT CRT; RV high posterior septum CRT in heart failure; Right ventricular apex v.s. high posterior septum High posterior septal lead placement in CRT
- Primary Outcome Measures
Name Time Method Echocardiographic reverse remodelling and dyssynchrony 3, 6, 12, 18 and 24 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Haukeland University Hospital
🇳🇴Bergen, Norway