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

Permanent Atrial Fibrillation Clinical Trial

— APAF-CRT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02137187
• Other study ID #: CPMCV-01-14
• Status: Recruiting
• Phase: Phase 3
• Start date: October 15, 2014
• Est. completion date: July 31, 2021

Study information

• Verified date: July 2020
• Source: Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella
• Contact: Michele Brignole, MD
• Phone: +39 0185 329567
• Email: mbrignole[@]asl4.liguria.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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%

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1830
• Est. completion date: July 31, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Permanent Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Italy	Department of Cardiology, Ospedali del Tigullio	Lavagna

Sponsors (1)

Lead Sponsor	Collaborator
Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. E — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined end-point	"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	Upto 3 years
Secondary	Major clinical events	"Morbidity trial" end-points Secondary end-points: total mortality, total hospitalizations, hospitalization for heart failure and/or atrial fibrillation and worsening heart failure.	Up to 3 years
Secondary	Major clinical events	"Mortality trial" end-points Secondary end-point: cardiovascular mortality and hospitalization for heart failure or uncontrolled intolerable atrial fibrillation	Up to 5 years