Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D) (NCT01233648) | Clinical Trial Compass
CompletedPhase 4
Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)
United States52 participantsStarted 2006-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.