Spanish Atrial Fibrillation And Resynchronization Study

Atrial Fibrillation Clinical Trial

— SPAREIII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181414
• Other study ID #: SPARE III - 2010
• Status: Completed
• Phase: Phase 4
• First received: August 2, 2010
• Last updated: March 9, 2015
• Start date: October 2010
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Dilated cardiomyopathy (LVEDD >56 mm)

• wide QRS (> 120 msec)

• NYHA III-IV

• EF<35%

• Permanent AF

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiomyopathies
• Cardiomyopathy, Dilated
• Chronic Heart Failure

Intervention

Procedure:
• Atrio ventricular junction ablation with radio-frequency
Atrioventricular junction ablation by using radiofrequency energy.

Drug:
• Beta blocker/digoxine/amiodarone
Ventricular rate control by using drug treatment.

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (8)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No