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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1830 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-15

Study Completion Date

2021-07-31

Brief Summary

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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

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Detailed Description

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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%

Conditions

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Permanent Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug therapy

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

Group Type EXPERIMENTAL

Optimized drug therapy

Intervention Type DRUG

Optimized drug therapy for heart failure and atrial fibrillation rate control

ICD

Intervention Type DEVICE

Implantable defibrillator (in control Group or in association with CRT in study Group) according to guidelines

Device: AV junction ablation & CRT

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

Group Type ACTIVE_COMPARATOR

AV junction ablation

Intervention Type PROCEDURE

AV junction ablation

CRT

Intervention Type DEVICE

Implantation of device for pacing and cardiac resynchronization therapy (CRT-P or CRT-D according to guidelines)

Optimized drug therapy

Intervention Type DRUG

Optimized drug therapy for heart failure and atrial fibrillation rate control

ICD

Intervention Type DEVICE

Implantable defibrillator (in control Group or in association with CRT in study Group) according to guidelines

Interventions

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AV junction ablation

Intervention Type PROCEDURE

CRT

Implantation of device for pacing and cardiac resynchronization therapy (CRT-P or CRT-D according to guidelines)

Intervention Type DEVICE

Optimized drug therapy

Optimized drug therapy for heart failure and atrial fibrillation rate control

Intervention Type DRUG

ICD

Implantable defibrillator (in control Group or in association with CRT in study Group) according to guidelines

Intervention Type DEVICE

Other Intervention Names

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AV nodal ablation Cardiac resynchronization therapy Pharmacological therapy Implantable defibrillator

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No