Atrioventricular Junction Ablation and Biventricular Pacing for Atrial Fibrillation and Heart Failure — APAF-CRT  

Permanent Atrial Fibrillation Clinical Trial

Official title: A Randomized Controlled Trial of Atrioventricular (AV) Junction Ablation and Biventricular Pacing Versus Optimal Pharmacological Therapy in Patients With Permanent Atrial Fibrillation

Status Recruiting

Clinical Trial Summary

There is evidence of superiority of AV junction ablation strategy over pharmacological therapy only for symptoms of atrial fibrillation, but not for heart failure, hospitalization, morbidity and mortality. Hypothesis of trial is that AV junction ablation is superior to pharmacological therapy as regard hospitalization and mortality

Clinical Trial Description

Prospective randomized, controlled, investigator-initiated trial which consists of two specific consecutive(overlapped) phases:

"Morbidity trial" (APAF-CRT morbidity). Small size (280 pts), follow-up 24 months. Primary endpoint: combined of mortality due to heartfailure, hospitalization for heart failure or atrial fibrillation or worsening heart failure. Predefined subgroup analysis for patients with ejection fraction ≤35% versus >35%

"Mortality trial" (APAF-CRT mortality). Large size (pts included in morbidity trial plus additional ~1500 pts, long-term follow-up (at least 4 years). Primary endpoint: total mortality. Predefined subgroup analysis for patients with ejection fraction ≤35% versus >35% ;

Related Conditions & MeSH terms

• Atrial Fibrillation
• Permanent Atrial Fibrillation

• NCT number: NCT02137187
• Study type: Interventional
• Source: Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella
• Contact: Michele Brignole, MD
• Phone: +39 0185 329567
• Email: mbrignole@asl4.liguria.it
• Status: Recruiting
• Phase: Phase 3
• Start date: October 15, 2014
• Completion date: July 31, 2021