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

Phase 3

• Conditions: Permanent Atrial Fibrillation
• Interventions: Drug: Optimized drug therapy; Procedure: AV junction ablation; Device: ICD; Device: CRT

• Registration Number: NCT02137187
• Lead Sponsor: Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella

Brief 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%

Study Timeline

• Study First Submitted: 2014-05-03
• Study First Submitted QC: 2014-05-10
• Study First Posted: 2014-05-13
• Study Start: 2014-10-15
• Status Verified: 2020-07
• Last Update Submitted: 2021-01-18
• Last Update Posted: 2021-01-20
• Primary Completion: 2021-05-15
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1830

Inclusion Criteria

To be eligible, each patient must be in the following condition:

1. Permanent atrial fibrillation (>6 months) which has been considered unsuitable for ablation or failed ablation
2. Narrow QRS ≤ 110 ms
3. Severely symptomatic (atrial fibrillation-related symptoms), refractory to drug therapy for rate control
4. At least one hospitalization related to atrial fibrillation and/or heart failure in the previous year (see definition below)

Exclusion Criteria

1. New York Heart Association (NYHA) class IV and systolic blood pressure <80 mmHg despite optimized therapy;
2. severe concomitant non-cardiac disease;
3. need for surgical intervention;
4. myocardial infarction within the previous 3 months;
5. previous implanted devices (PM/ICD/CRT)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug therapy	ICD	Control Arm: optimized drug therapy (plus implantable defibrillator (ICD) according to guidelines)
Device: AV junction ablation & CRT	ICD	AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy
Drug therapy	Optimized drug therapy	Control Arm: optimized drug therapy (plus implantable defibrillator (ICD) according to guidelines)
Device: AV junction ablation & CRT	AV junction ablation	AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy
Device: AV junction ablation & CRT	CRT	AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy
Device: AV junction ablation & CRT	Optimized drug therapy	AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy

Primary Outcome Measures

Name	Time	Method
Combined end-point	Upto 3 years	"Morbidity trial" end-points Primary end-point: a combined of (1) mortality due to heart failure, (2) hospitalization for heart failure or uncontrolled intolerable atrial fibrillation, or (3) worsening heart failure

Secondary Outcome Measures

Name	Time	Method
Major clinical events	Up to 5 years	"Mortality trial" end-points Secondary end-point: cardiovascular mortality and hospitalization for heart failure or uncontrolled intolerable atrial fibrillation

Trial Locations

Locations (1)

Department of Cardiology, Ospedali del Tigullio; 🇮🇹 Lavagna, Italy