SPAREIII: Spanish Atrial Fibrillation And Resynchronization Study

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Completed

CT.gov ID

NCT01181414

Collaborator

University of Navarrra Hospital (Clinica Universitaria) (Other), Fundación para la Investigación del Hospital Clínico de Valencia (Other), Puerta de Hierro University Hospital (Other), Hospital Universitario Ramon y Cajal (Other), Hospital Universitario La Fe (Other), Hospital Universitario La Paz (Other), Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Other)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure Cardiomyopathy, Dilated Atrial Fibrillation	Procedure: Atrio ventricular junction ablation with radio-frequency Drug: Beta blocker/digoxine/amiodarone	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atrioventricular junction ablation Atrioventricular junction ablation by using radiofrequency energy.	Procedure: Atrio ventricular junction ablation with radio-frequency Atrioventricular junction ablation by using radiofrequency energy.
Active Comparator: Drug control of ventricular rate Drug control of ventricular rate.	Drug: Beta blocker/digoxine/amiodarone Ventricular rate control by using drug treatment. Other Names: Negative chronotropic drugs pharmacological treatment .

Arm

Intervention/Treatment

Experimental: Atrioventricular junction ablation

Atrioventricular junction ablation by using radiofrequency energy.

Procedure: Atrio ventricular junction ablation with radio-frequency

Atrioventricular junction ablation by using radiofrequency energy.

Active Comparator: Drug control of ventricular rate

Drug control of ventricular rate.

Drug: Beta blocker/digoxine/amiodarone

Ventricular rate control by using drug treatment.

Other Names:

Negative chronotropic drugs pharmacological treatment .

Outcome Measures

Primary Outcome Measures

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

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%.