A Randomized Controlled Trial of Atrioventricular (AV) Junction Ablation and Biventricular Pacing Versus Optimal Pharmacological Therapy in Patients With Permanent Atrial Fibrillation
Overview
- Phase
- Phase 3
- Intervention
- Optimized drug therapy
- Conditions
- Permanent Atrial Fibrillation
- Sponsor
- Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella
- Enrollment
- 1830
- Locations
- 1
- Primary Endpoint
- Combined end-point
- Last Updated
- 5 years ago
Overview
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%
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be eligible, each patient must be in the following condition:
- •Permanent atrial fibrillation (\>6 months) which has been considered unsuitable for ablation or failed ablation
- •Narrow QRS ≤ 110 ms
- •Severely symptomatic (atrial fibrillation-related symptoms), refractory to drug therapy for rate control
- •At least one hospitalization related to atrial fibrillation and/or heart failure in the previous year (see definition below)
Exclusion Criteria
- •New York Heart Association (NYHA) class IV and systolic blood pressure \<80 mmHg despite optimized therapy;
- •severe concomitant non-cardiac disease;
- •need for surgical intervention;
- •myocardial infarction within the previous 3 months;
- •previous implanted devices (PM/ICD/CRT)
Arms & Interventions
Drug therapy
Control Arm: optimized drug therapy (plus implantable defibrillator (ICD) according to guidelines)
Intervention: Optimized drug therapy
Drug therapy
Control Arm: optimized drug therapy (plus implantable defibrillator (ICD) according to guidelines)
Intervention: ICD
Device: AV junction ablation & CRT
AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy
Intervention: AV junction ablation
Device: AV junction ablation & CRT
AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy
Intervention: CRT
Device: AV junction ablation & CRT
AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy
Intervention: Optimized drug therapy
Device: AV junction ablation & CRT
AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy
Intervention: ICD
Outcomes
Primary Outcomes
Combined end-point
Time Frame: 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 Outcomes
- Major clinical events(Up to 5 years)