Catheter Ablation vs. Medical Therapy in Congested Hearts With AF (NCT02686749) | Clinical Trial Compass
TerminatedPhase 4
Catheter Ablation vs. Medical Therapy in Congested Hearts With AF
Stopped: unable to reach enrollment goal
United States4 participantsStarted 2016-06
Plain-language summary
This study is a multi-center, randomized, unblinded, clinical trial. The objective is to determine if catheter-based atrial fibrillation (AF) ablation is superior to medical treatment in patients with impaired left ventricular (LV) function who have been diagnosed with symptomatic AF within the past 12 months.
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:
* must be 18 years of age or older
* Provide signed written Informed Consent
* symptomatic AF documented by EKG or heart rhythm monitoring within 12 months
* patients should be on optimal medical therapy for heart failure for 3 months prior to randomization. Adjustments to medications within this 3 month period are permitted.
* chronically impaired LV function defined as EF between 20%-45% within last 3 months
* all patients should be on an optimal therapy for impaired LV function
* ability to complete 6 minute walk test
* eligible for catheter ablation and anti-arrhythmic drugs
Exclusion Criteria:
* women of childbearing potential unless post- menopausal or surgically sterile
* patients hospitalized for heart failure within the 3 months prior to randomization
* reversible causes of AF such as pericarditis, thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma
* recent reversible LV impairment that may be attributed to AF with rapid ventricular response and may improve with introduction of rate control
* valvular heart disease requiring surgical intervention
* Coronary Artery Disease (CAD) requiring surgical or percutaneous intervention
* early post-operative AF (within 3 months of surgery)
* previous MAZE or left atrial instrumentation (including ablation and left atrial appendage exclusion)
* history of Atrioventricular Node (AVN) ablation
* hypertrophic cardiomyopathy
* prolonged QT interval
* liver failure
* renal…
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.
What they're measuring
1
First Hospitalization for Heart Failure, Recurrence of AF or Direct Current Cardioversion