Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)
This study is enrolling participants by invitation only.
Sponsor:
University of Pittsburgh
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
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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
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 June 17, 2013