AVJ Ablation Followed by Resynchronization Therapy in Patients With CHF and AF (AVERT-AF)

February 1, 2019 updated by: Abbott Medical Devices

AVERT-AF: Atrio-VEntricular Junction Ablation Followed by Resynchronization Therapy in Patients With Congestive Heart Failure and Atrial Fibrillation

The purpose of the study is to determine if the combination of AVJ ablation followed by BiV pacing significantly improves functional status and exercise capacity compared to pharmacologic rate control in patients with chronic AF and depressed ejection fraction, regardless of rate or QRS duration.

Study Overview

Status

Terminated

Conditions

Detailed Description

  • This is a prospective, randomized, double blinded, multicenter study
  • Patients meeting all the enrollment criteria are screened at enrollment and randomized to Group 1 (Pharmacological therapy + Single Chamber ICD) or Group 2 (AVJ Ablation + CRT-D)
  • Screened patients are implanted with a FDA approved SJM ICD/CRT-D with compatible lead system
  • Patients are followed at 1, 3, 6 and 12 months post implant
  • Total # of centers - 20 centers
  • Sample size - 180 patients

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

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

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah

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

Sampling Method

Probability Sample

Study Population

Patient with history of permanent AF and CHF

Description

Inclusion Criteria:

  • Symptomatic permanent AF
  • Class I or II indication for ICD
  • LVEF ≤ 35% within 6 months
  • NYHA class II or III with a history of CHF
  • Maximal tolerated drug therapy for CHF and rate control with a stable regimen for ≥ 30 days
  • Ability to independently comprehend and complete a QoL questionnaire
  • Ability to give informed consent for study participation and willingness and ability to comply with prescribed follow-up tests and scheduled evaluations

Exclusion Criteria:

  • Paroxysmal or persistent AF
  • Class I indication for pacing (including AVJ ablation for poor rate control)
  • Ability to walk ≥ 450 meters in 6 minutes
  • Musculoskeletal disorders that prohibit the completion of a 450 meters walk
  • NYHA class I or IV at the time of enrollment
  • A contraindication to taking Coumadin therapy
  • History of myocardial infarction, percutanous coronary intervention, or CABG in the past 30 days
  • History of mitral valve surgery
  • Prior attempts for cardiac resynchronization therapy
  • The presence of an existing coronary sinus lead or epicardial lead
  • Life expectancy < 1year
  • Age < 18 yrs
  • Current participation in other clinical studies except registry trials
  • Use of calcium channel blockers
  • Pregnancy
  • Inability to give informed consent

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

Cohorts and Interventions

Group / Cohort
CRT-D + AVJ Ablation
Single-Chamber ICD + Pharmacological Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exercise duration
Time Frame: 12 month post implant
12 month post implant

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life (QOL) via Minnesota Living With Heart Failure (MLWH) questionnaire
Time Frame: 12 month post implant
12 month post implant
NYHA Class Progression
Time Frame: 12 month post implant
12 month post implant
LVEF
Time Frame: 12 month post implant
12 month post implant

Collaborators and Investigators

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

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Mohamed Hamdan, MD, University of Utah Health Sciences

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

June 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

October 19, 2007

First Submitted That Met QC Criteria

October 22, 2007

First Posted (Estimate)

October 23, 2007

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD 310

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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