Spanish Atrial Fibrillation And Resynchronization Study

Phase 4

Completed

• Conditions: Chronic Heart Failure; Atrial Fibrillation; Cardiomyopathy, Dilated
• Interventions: Procedure: Atrio ventricular junction ablation with radio-frequency; Drug: Beta blocker/digoxine/amiodarone

• Registration Number: NCT01181414
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Study Start: 2010-10
• Primary Completion: 2014-11
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Dilated cardiomyopathy (LVEDD >56 mm)
• wide QRS (> 120 msec)
• NYHA III-IV
• EF<35%
• Permanent AF

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atrioventricular junction ablation	Atrio ventricular junction ablation with radio-frequency	Atrioventricular junction ablation by using radiofrequency energy.
Drug control of ventricular rate	Beta blocker/digoxine/amiodarone	Drug control of ventricular rate.

Primary Outcome Measures

Name	Time	Method
Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation.	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 Outcome Measures

Name	Time	Method
Clinical response to Cardiac resynchronization therapy.	1-year follow-up	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%.

Trial Locations

Locations (1)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain