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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01233648
First received: November 2, 2010
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Other: rate control via CRT-D and AVN ablation
Other: rhythm control via pharmacologic, electrical or ablative therapies
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • AF burden [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AF Other: rate control via CRT-D and AVN ablation
rate control
Active Comparator: SR Other: rhythm control via pharmacologic, electrical or ablative therapies
rhythm control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233648

Locations
United States, Pennsylvania
UPMC Cardiovascular Institute
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: David S. Schwartzman, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01233648     History of Changes
Other Study ID Numbers: 0601113
Study First Received: November 2, 2010
Last Updated: November 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
heart failure
CRT-D

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014