Atrial Fibrillation Clinical Trial
— SPAREIIIOfficial title:
Phase 4. Study of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation.
Verified date | March 2015 |
Source | Hospital Clinic of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 2015 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Dilated cardiomyopathy (LVEDD >56 mm) - wide QRS (> 120 msec) - NYHA III-IV - EF<35% - Permanent AF |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic de Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona | Fundación para la Investigación del Hospital Clínico de Valencia, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla, Hospital Universitario La Fe, Hospital Universitario La Paz, Hospital Universitario Ramon y Cajal, Puerta de Hierro University Hospital, University of Navarrra Hospital (Clinica Universitaria) |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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%. | 1-year follow-up | No |
Secondary | 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%. | 1-year follow-up | No |
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