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Spanish Atrial Fibrillation And Resynchronization Study (SPAREIII)

Primary Purpose

Chronic Heart Failure, Cardiomyopathy, Dilated, Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Atrio ventricular junction ablation with radio-frequency
Beta blocker/digoxine/amiodarone
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Permanent Atrial Fibrillation, Resynchronization therapy, Ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Hospital Clinic de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atrioventricular junction ablation

Drug control of ventricular rate

Arm Description

Atrioventricular junction ablation by using radiofrequency energy.

Drug control of ventricular rate.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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%.

Full Information

First Posted
August 2, 2010
Last Updated
March 9, 2015
Sponsor
Hospital Clinic of Barcelona
Collaborators
University of Navarrra Hospital (Clinica Universitaria), Fundación para la Investigación del Hospital Clínico de Valencia, Puerta de Hierro University Hospital, Hospital Universitario Ramon y Cajal, Hospital Universitario La Fe, Hospital Universitario La Paz, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT01181414
Brief Title
Spanish Atrial Fibrillation And Resynchronization Study
Acronym
SPAREIII
Official Title
Phase 4. Study of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
University of Navarrra Hospital (Clinica Universitaria), Fundación para la Investigación del Hospital Clínico de Valencia, Puerta de Hierro University Hospital, Hospital Universitario Ramon y Cajal, Hospital Universitario La Fe, Hospital Universitario La Paz, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Cardiomyopathy, Dilated, Atrial Fibrillation
Keywords
Permanent Atrial Fibrillation, Resynchronization therapy, Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atrioventricular junction ablation
Arm Type
Experimental
Arm Description
Atrioventricular junction ablation by using radiofrequency energy.
Arm Title
Drug control of ventricular rate
Arm Type
Active Comparator
Arm Description
Drug control of ventricular rate.
Intervention Type
Procedure
Intervention Name(s)
Atrio ventricular junction ablation with radio-frequency
Intervention Description
Atrioventricular junction ablation by using radiofrequency energy.
Intervention Type
Drug
Intervention Name(s)
Beta blocker/digoxine/amiodarone
Other Intervention Name(s)
Negative chronotropic drugs pharmacological treatment .
Intervention Description
Ventricular rate control by using drug treatment.
Primary Outcome Measure Information:
Title
Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation.
Description
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%.
Time Frame
1-year follow-up
Secondary Outcome Measure Information:
Title
Clinical response to Cardiac resynchronization therapy.
Description
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%.
Time Frame
1-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dilated cardiomyopathy (LVEDD >56 mm) wide QRS (> 120 msec) NYHA III-IV EF<35% Permanent AF
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose M Tolosana, M.D.
Organizational Affiliation
Hospital Clinic, University of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

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Spanish Atrial Fibrillation And Resynchronization Study

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