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

Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella

Status and phase: Unknown; Phase 3

Conditions: Permanent Atrial Fibrillation

Treatments: Device: ICD; Device: CRT; Drug: Optimized drug therapy; Procedure: AV junction ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02137187

CPMCV-01-14

Details and patient eligibility

About

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

Full 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%

Enrollment: 1,830 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,830 participants in 2 patient groups

Drug therapy

Experimental group

Description:

Control Arm: optimized drug therapy (plus implantable defibrillator (ICD) according to guidelines)

Treatment:

Drug: Optimized drug therapy

Device: ICD

Device: AV junction ablation & CRT

Active Comparator group

Description:

AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy

Treatment:

Procedure: AV junction ablation

Drug: Optimized drug therapy

Device: CRT

Device: ICD