Spanish Atrial Fibrillation And Resynchronization Study (SPAREIII)

This study is ongoing, but not recruiting participants.
Sponsor:
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
Information provided by (Responsible Party):
Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01181414
First received: August 2, 2010
Last updated: March 17, 2014
Last verified: March 2014

August 2, 2010
March 17, 2014
October 2010
October 2014   (final data collection date for primary outcome measure)
Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation. [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
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%.
Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation. [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
Comparison of echocardiographic responders in patients with Atrial fibrillation treated with cardiac resynchronization therapy depending on if they have the atrio-ventricular junction ablated or not. Echocardiographic response was defined as left ventricular end-systolic volume reduction >10%.
Complete list of historical versions of study NCT01181414 on ClinicalTrials.gov Archive Site
Clinical response to Cardiac resynchronization therapy. [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
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%.
Clinical response to Cardiac resynchronization therapy. [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
Comparison of clinical response in patients with permanent atrial fibrillation treated with cardiac resynchronization therapy, depending if they have the atrio-ventricular junction ablated or not. Clinical response is defined as not death or heart transplantation and improvement of the distance walked in the 6-minute walking test >10%.
Not Provided
Not Provided
 
Spanish Atrial Fibrillation And Resynchronization Study
Phase 4. Study of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Heart Failure
  • Cardiomyopathy, Dilated
  • Atrial Fibrillation
  • 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.
    Other Name: Negative chronotropic drugs pharmacological treatment .
  • Experimental: Atrioventricular junction ablation
    Atrioventricular junction ablation by using radiofrequency energy.
    Intervention: Procedure: Atrio ventricular junction ablation with radio-frequency
  • Active Comparator: Drug control of ventricular rate
    Drug control of ventricular rate.
    Intervention: Drug: Beta blocker/digoxine/amiodarone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Dilated cardiomyopathy (LVEDD >56 mm)
  • wide QRS (> 120 msec)
  • NYHA III-IV
  • EF<35%
  • Permanent AF
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01181414
SPARE III - 2010
Yes
Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
  • 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
Principal Investigator: Jose M Tolosana, M.D. Hospital Clinic, University of Barcelona
Hospital Clinic of Barcelona
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP