Status:
COMPLETED
Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)
Lead Sponsor:
University of Pittsburgh
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 abla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01233648
Start Date
June 1 2006
End Date
November 1 2015
Last Update
March 23 2023
Active Locations (1)
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1
UPMC Cardiovascular Institute
Pittsburgh, Pennsylvania, United States, 15213