Spanish Atrial Fibrillation And Resynchronization Study (SPAREIII)

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: Cardiomyopathy, Dilated; Atrial Fibrillation; Chronic Heart Failure

Treatments: Drug: Beta blocker/digoxine/amiodarone; Procedure: Atrio ventricular junction ablation with radio-frequency

Study type: Interventional

Funder types: Other

Identifiers

NCT01181414

SPARE III - 2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Atrioventricular junction ablation

Experimental group

Description:

Atrioventricular junction ablation by using radiofrequency energy.

Treatment:

Procedure: Atrio ventricular junction ablation with radio-frequency

Drug control of ventricular rate

Active Comparator group

Description:

Drug control of ventricular rate.

Treatment:

Drug: Beta blocker/digoxine/amiodarone