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Spanish Atrial Fibrillation And Resynchronization Study (SPAREIII)

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ClinicalTrials.gov Identifier: NCT01181414
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : March 10, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Cardiomyopathy, Dilated Atrial Fibrillation Procedure: Atrio ventricular junction ablation with radio-frequency Drug: Beta blocker/digoxine/amiodarone Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4. Study of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation.
Study Start Date : October 2010
Primary Completion Date : November 2014
Study Completion Date : January 2015

Arms and Interventions

Arm Intervention/treatment
Experimental: Atrioventricular junction ablation
Atrioventricular junction ablation by using radiofrequency energy.
Procedure: Atrio ventricular junction ablation with radio-frequency
Atrioventricular junction ablation by using radiofrequency energy.
Active Comparator: Drug control of ventricular rate
Drug control of ventricular rate.
Drug: Beta blocker/digoxine/amiodarone
Ventricular rate control by using drug treatment.
Other Name: Negative chronotropic drugs pharmacological treatment .

Outcome Measures

Primary Outcome Measures :
  1. Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation. [ Time Frame: 1-year follow-up ]
    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 :
  1. Clinical response to Cardiac resynchronization therapy. [ Time Frame: 1-year follow-up ]
    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%.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Dilated cardiomyopathy (LVEDD >56 mm)
  • wide QRS (> 120 msec)
  • EF<35%
  • Permanent AF
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181414

Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
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
More Information

Responsible Party: Josep Lluis Mont Girbau, Head of the Arrhythmia Unit, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01181414     History of Changes
Other Study ID Numbers: SPARE III - 2010
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015

Keywords provided by Josep Lluis Mont Girbau, Hospital Clinic of Barcelona:
Permanent Atrial Fibrillation
Resynchronization therapy

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors