Phase 4. Study of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation.
Overview
- Phase
- Phase 4
- Intervention
- Atrio ventricular junction ablation with radio-frequency
- Conditions
- Chronic Heart Failure
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The aim of the present study is to compare the response to cardiac resynchronization therapy (CRT) in patients with chronic advanced heart failure and permanent atrial fibrillation (AF) depending on atrio ventricular junction (AVJ) is ablated or not.
Detailed Description
Cardiac resynchronization therapy (CRT) improves the functional capacity and the quality of life and reduces the mortality of patients with dilated cardiomyopathy, low ejection fraction and wide QRS. Only 2% of patients included in CRT randomized trials were in AF. To obtain a good response to CRT, percentage \>90% of ventricular pacing must be obtained. Based on observational studies, current guidelines of CRT recommend the atrio ventricular junction (AVJ) ablation in those patients with permanent atrial fibrillation.
Investigators
Josep Lluis Mont Girbau
Head of the Arrhythmia Unit
Hospital Clinic of Barcelona
Eligibility Criteria
Inclusion Criteria
- •Dilated cardiomyopathy (LVEDD \>56 mm)
- •wide QRS (\> 120 msec)
- •NYHA III-IV
- •Permanent AF
Exclusion Criteria
- Not provided
Arms & Interventions
Atrioventricular junction ablation
Atrioventricular junction ablation by using radiofrequency energy.
Intervention: Atrio ventricular junction ablation with radio-frequency
Drug control of ventricular rate
Drug control of ventricular rate.
Intervention: Beta blocker/digoxine/amiodarone
Outcomes
Primary Outcomes
Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation.
Time Frame: 1-year follow-up
Comparison of echocardiographic responders in patients with permanent atrial fibrillation submitted to cardiac resynchronization therapy depending on whether the atrio-ventricular junction is ablated or not. Echocardiographic response was defined as left ventricular end-systolic volume reduction \>10%.
Secondary Outcomes
- Clinical response to Cardiac resynchronization therapy.(1-year follow-up)