NCT02137187

Atrioventricular Junction Ablation and Biventricular Pacing for Atrial Fibrillation and Heart Failure

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,830 (estimated)
• Sponsor: Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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%

Conditions

• Permanent Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	AV junction ablation	AV junction ablation
DEVICE	CRT	Implantation of device for pacing and cardiac resynchronization therapy (CRT-P or CRT-D according to guidelines)
DRUG	Optimized drug therapy	Optimized drug therapy for heart failure and atrial fibrillation rate control
DEVICE	ICD	Implantable defibrillator (in control Group or in association with CRT in study Group) according to guidelines

Timeline

• Start date: 2014-10-15
• Primary completion: 2021-05-15
• Completion: 2021-07-31
• First posted: 2014-05-13
• Last updated: 2021-01-20

Locations

1 site across 1 country: Italy