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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01181414
Other study ID # SPARE III - 2010
Secondary ID
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


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
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