Clinical trial NCT02137187: Atrioventricular Junction Ablation and Biventricular Pacing for Atrial Fibrillation and Heart Failure
Official title: A Randomized Controlled Trial of Atrioventricular (AV) Junction Ablation and Biventricular Pacing Versus Optimal Pharmacological Therapy in Patients With Permanent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Permanent Atrial Fibrillation
Keywords: Atrial fibrillation
Heart failure
Catheter ablation
Cardiac resynchronization therapy
Implantable defibrillator
Lead sponsor: Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 1830
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%

Eligibility criteria: 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)

Primary outcomes:
measure: Combined end-point
timeFrame: Upto 3 years
Secondary outcomes:
measure: Major clinical events
timeFrame: Up to 3 years
measure: Major clinical events
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Lavagna
country: Italy
facility: Department of Cardiology, Ospedali del Tigullio
Study officials:
affiliation: Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella
name: Claudio Marsano, MD
role: STUDY_DIRECTOR
References:
citation: Chatterjee NA, Upadhyay GA, Ellenbogen KA, McAlister FA, Choudhry NK, Singh JP. Atrioventricular nodal ablation in atrial fibrillation: a meta-analysis and systematic review. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):68-76. doi: 10.1161/CIRCEP.111.967810. Epub 2011 Dec 20.
citation: Brignole M, Botto G, Mont L, Iacopino S, De Marchi G, Oddone D, Luzi M, Tolosana JM, Navazio A, Menozzi C. Cardiac resynchronization therapy in patients undergoing atrioventricular junction ablation for permanent atrial fibrillation: a randomized trial. Eur Heart J. 2011 Oct;32(19):2420-9. doi: 10.1093/eurheartj/ehr162. Epub 2011 May 23.
citation: Brignole M, Pentimalli F, Palmisano P, Landolina M, Quartieri F, Occhetta E, Calo L, Mascia G, Mont L, Vernooy K, van Dijk V, Allaart C, Fauchier L, Gasparini M, Parati G, Soranna D, Rienstra M, Van Gelder IC; APAF-CRT Trial Investigators. AV junction ablation and cardiac resynchronization for patients with permanent atrial fibrillation and narrow QRS: the APAF-CRT mortality trial. Eur Heart J. 2021 Dec 7;42(46):4731-4739. doi: 10.1093/eurheartj/ehab569.
citation: Brignole M, Pokushalov E, Pentimalli F, Palmisano P, Chieffo E, Occhetta E, Quartieri F, Calo L, Ungar A, Mont L; APAF-CRT Investigators. A randomized controlled trial of atrioventricular junction ablation and cardiac resynchronization therapy in patients with permanent atrial fibrillation and narrow QRS. Eur Heart J. 2018 Dec 1;39(45):3999-4008. doi: 10.1093/eurheartj/ehy555.