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

Primary Purpose

Permanent Atrial Fibrillation

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
AV junction ablation
CRT
Optimized drug therapy
ICD
Sponsored by
Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Permanent Atrial Fibrillation focused on measuring Atrial fibrillation, Heart failure, Catheter ablation, Cardiac resynchronization therapy, Implantable defibrillator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Department of Cardiology, Ospedali del TigullioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug therapy

Device: AV junction ablation & CRT

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Major clinical events
"Mortality trial" end-points Secondary end-point: cardiovascular mortality and hospitalization for heart failure or uncontrolled intolerable atrial fibrillation

Full Information

First Posted
May 3, 2014
Last Updated
January 18, 2021
Sponsor
Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella
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1. Study Identification

Unique Protocol Identification Number
NCT02137187
Brief Title
Atrioventricular Junction Ablation and Biventricular Pacing for Atrial Fibrillation and Heart Failure
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2014 (Actual)
Primary Completion Date
May 15, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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%

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Permanent Atrial Fibrillation
Keywords
Atrial fibrillation, Heart failure, Catheter ablation, Cardiac resynchronization therapy, Implantable defibrillator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1830 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug therapy
Arm Type
Experimental
Arm Description
Control Arm: optimized drug therapy (plus implantable defibrillator (ICD) according to guidelines)
Arm Title
Device: AV junction ablation & CRT
Arm Type
Active Comparator
Arm Description
AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy
Intervention Type
Procedure
Intervention Name(s)
AV junction ablation
Other Intervention Name(s)
AV nodal ablation
Intervention Description
AV junction ablation
Intervention Type
Device
Intervention Name(s)
CRT
Other Intervention Name(s)
Cardiac resynchronization therapy
Intervention Description
Implantation of device for pacing and cardiac resynchronization therapy (CRT-P or CRT-D according to guidelines)
Intervention Type
Drug
Intervention Name(s)
Optimized drug therapy
Other Intervention Name(s)
Pharmacological therapy
Intervention Description
Optimized drug therapy for heart failure and atrial fibrillation rate control
Intervention Type
Device
Intervention Name(s)
ICD
Other Intervention Name(s)
Implantable defibrillator
Intervention Description
Implantable defibrillator (in control Group or in association with CRT in study Group) according to guidelines
Primary Outcome Measure Information:
Title
Combined end-point
Description
"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
Time Frame
Upto 3 years
Secondary Outcome Measure Information:
Title
Major clinical events
Description
"Morbidity trial" end-points Secondary end-points: total mortality, total hospitalizations, hospitalization for heart failure and/or atrial fibrillation and worsening heart failure.
Time Frame
Up to 3 years
Title
Major clinical events
Description
"Mortality trial" end-points Secondary end-point: cardiovascular mortality and hospitalization for heart failure or uncontrolled intolerable atrial fibrillation
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Brignole, MD
Phone
+39 0185 329567
Email
mbrignole@asl4.liguria.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Marsano, MD
Organizational Affiliation
Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella
Official's Role
Study Director
Facility Information:
Facility Name
Department of Cardiology, Ospedali del Tigullio
City
Lavagna
ZIP/Postal Code
16033
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Brignole, MD
Phone
0185329567
Email
mbrignole@asl4.liguria.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22187425
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.
Results Reference
background
PubMed Identifier
21606084
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.
Results Reference
result
PubMed Identifier
34453840
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. Erratum In: Eur Heart J. 2021 Oct 16;: Eur Heart J. 2021 Dec 08;:
Results Reference
derived
PubMed Identifier
30165479
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.
Results Reference
derived

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

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