Spanish Atrial Fibrillation And Resynchronization Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 4. Study of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation.

Conditions
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Chronic Heart Failure, Cardiomyopathy, Dilated, Atrial Fibrillation

Intervention / Treatment
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* Procedure: Atrio ventricular junction ablation with radio-frequency
* Drug: Beta blocker/digoxine/amiodarone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dilated cardiomyopathy (LVEDD >56 mm) wide QRS (> 120 msec) NYHA III-IV EF<35% Permanent AF

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atrioventricular junction ablation<br>Atrioventricular junction ablation by using radiofrequency energy. | Procedure: Atrio ventricular junction ablation with radio-frequency<br>* Atrioventricular junction ablation by using radiofrequency energy.<br>|
| Active Comparator: Drug control of ventricular rate<br>Drug control of ventricular rate. | Drug: Beta blocker/digoxine/amiodarone<br>* Ventricular rate control by using drug treatment.<br>* Other names: Negative chronotropic drugs pharmacological treatment .;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation. | 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%. | 1-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response to Cardiac resynchronization therapy. | Comparison of clinical response in patients with permanent atrial fibrillation submitted to cardiac resynchronization therapy, depending on whether the atrio-ventricular junction has been ablated or not. Clinical response is defined as not death/heart transplantation and improvement of the distance walked in the 6-minute walking test >10%. | 1-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Permanent Atrial Fibrillation, Resynchronization therapy, Ablation