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

January 18, 2021 updated by: Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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%

Study Type

Interventional

Enrollment (Anticipated)

1830

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Lavagna, Italy, 16033
        • Recruiting
        • Department of Cardiology, Ospedali del Tigullio
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug therapy
Control Arm: optimized drug therapy (plus implantable defibrillator (ICD) according to guidelines)
Drug: Optimized drug therapy
Optimized drug therapy for heart failure and atrial fibrillation rate control
Other Names:
  • Pharmacological therapy
Device: ICD
Implantable defibrillator (in control Group or in association with CRT in study Group) according to guidelines
Other Names:
  • Implantable defibrillator
Active Comparator: Device: AV junction ablation & CRT
AV junction ablation + CRT (CRT-P or CRT-D according to guidelines) + optimized drug therapy
Drug: Optimized drug therapy
Optimized drug therapy for heart failure and atrial fibrillation rate control
Other Names:
  • Pharmacological therapy
Device: ICD
Implantable defibrillator (in control Group or in association with CRT in study Group) according to guidelines
Other Names:
  • Implantable defibrillator
Procedure: AV junction ablation
AV junction ablation
Other Names:
  • AV nodal ablation
Device: CRT
Implantation of device for pacing and cardiac resynchronization therapy (CRT-P or CRT-D according to guidelines)
Other Names:
  • Cardiac resynchronization therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Upto 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major clinical events
Time Frame: Up to 3 years
"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
Major clinical events
Time Frame: Up to 5 years
"Mortality trial" end-points Secondary end-point: cardiovascular mortality and hospitalization for heart failure or uncontrolled intolerable atrial fibrillation
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella

Investigators

  • Study Director: Claudio Marsano, MD, Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2014

Primary Completion (Anticipated)

May 15, 2021

Study Completion (Anticipated)

July 31, 2021

Study Registration Dates

First Submitted

May 3, 2014

First Submitted That Met QC Criteria

May 10, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 18, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPMCV-01-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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