Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)

March 22, 2023 updated by: University of Pittsburgh
This study is being done to find out if controlling rate or controlling rhythm is better for heart failure patients who also have AF. Patients with AF who are receiving a CRT-D device and AV node ablation as part of their clinical care will be followed for one year. One group will have their heart rate controlled by the ICD and AVN ablation alone and the second group will be treated with the ICD, AVN ablation and standard medical therapies to restore the heart's normal rhythm. The study doctors will compare the information collected from all of the subjects in this study to see if treating rate or treating rhythm is better in patients with heart failure and AF, resulting in a better quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

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
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Cardiovascular Institute

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:

  • Having persistent AF, defined as AF that does not self terminate for at least 24 consecutive hours.
  • In AF upon entry into the operating room for CRT-D implantation and AV node ablation.
  • Being on a stable dosage of an ACE inhibitor or ARB for at least 1 month preceding implant
  • Being on a Beta-blocker for at least 3 months preceding implant and a stable dosage within 1 month of implant
  • Not taking or able to be taken off all type I/III antiarrhythmic medications.
  • Taking Coumadin so as to maintain an INR of between 2 and 3.
  • A Class I or IIa ICD indication
  • NYHA Class III/IV within 1 month of baseline
  • Intrinsic QRS duration ≥ 130 ms within 1 month prior to baseline
  • Left ventricular ejection fraction ≤ 35% (method per physician discretion) within 1 month prior to baseline
  • Left ventricular end diastolic dimension (LVEDD) ≥ 55 mm (method per physician discretion) within 1 months prior to baseline
  • Willing to provide written informed consent
  • Are expected to survive for 6 month of study participation
  • Able to tolerate an urgent thoracotomy
  • Able to tolerate < 1 mg dexamethasone sodium phosphate (steroid)

Exclusion Criteria:

  • Having self-terminating or interminable AF
  • Having unstable angina, or having experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within the past 1 month
  • Post-heart transplant (patients on heart transplant list for the first time are not excluded)
  • Having mechanical right heart valve
  • Having an existing CRT or atrial therapy device(s)
  • Being enrolled in any concurrent drug and/or device study which would confound the results of this trial
  • Having primary valvular disease and indicated for valve repair or replacement
  • Having a previous AV node ablation
  • Being on a Type I or Type III anti-arrhythmic medication for the treatment of ventricular tachyarrhythmias
  • Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SR
Other: rhythm control via pharmacologic, electrical or ablative therapies
rhythm control
Active Comparator: AF
Other: rate control via CRT-D and AVN ablation
rate control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AF burden
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: David S. Schwartzman, MD, University of Pittsburgh

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, 2006

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

November 2, 2010

First Submitted That Met QC Criteria

November 2, 2010

First Posted (Estimate)

November 3, 2010

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0601113

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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