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Spanish Atrial Fibrillation And Resynchronization Study

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01181414
Acronym
SPAREIII
Enrollment
60
Registered
2010-08-13
Start date
2010-10-31
Completion date
2015-01-31
Last updated
2015-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Cardiomyopathy, Dilated, Chronic Heart Failure

Keywords

Permanent Atrial Fibrillation, Resynchronization therapy, Ablation

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.

Interventions

PROCEDUREAtrio ventricular junction ablation with radio-frequency

Atrioventricular junction ablation by using radiofrequency energy.

DRUGBeta blocker/digoxine/amiodarone

Ventricular rate control by using drug treatment.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation.1-year follow-upComparison 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

MeasureTime frameDescription
Clinical response to Cardiac resynchronization therapy.1-year follow-upComparison 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%.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026