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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
rate control via CRT-D and AVN ablation
rhythm control via pharmacologic, electrical or ablative therapies
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation focused on measuring heart failure, CRT-D

Eligibility Criteria

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

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

Sites / Locations

  • UPMC Cardiovascular Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AF

SR

Arm Description

Outcomes

Primary Outcome Measures

AF burden

Secondary Outcome Measures

Full Information

First Posted
November 2, 2010
Last Updated
March 22, 2023
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01233648
Brief Title
Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)
Official Title
Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
heart failure, CRT-D

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AF
Arm Type
Active Comparator
Arm Title
SR
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
rate control via CRT-D and AVN ablation
Intervention Description
rate control
Intervention Type
Other
Intervention Name(s)
rhythm control via pharmacologic, electrical or ablative therapies
Intervention Description
rhythm control
Primary Outcome Measure Information:
Title
AF burden
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S. Schwartzman, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Cardiovascular Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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

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