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Completed

NCT Number: NCT01181414

Spanish Atrial Fibrillation And Resynchronization Study

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.

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Key information

Conditions

Chronic Heart Failure Arrhythmias, Cardiac Atrial Fibrillation Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Laminopathies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Atrio ventricular junction ablation with radio-frequency

Procedure

Atrioventricular junction ablation by using radiofrequency energy.

Beta blocker/digoxine/amiodarone

Drug

Ventricular rate control by using drug treatment.

Other names: Negative chronotropic drugs pharmacological treatment .

Primary outcomes

  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 outcomes

  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%.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SPAREIII

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Aug 13, 2010
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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