A Prospective Study of Medical Therapy Against Cryoballoon Ablation in Symptomatic Recent Onset P… (NCT02389218) | Clinical Trial Compass
CompletedPhase 4
A Prospective Study of Medical Therapy Against Cryoballoon Ablation in Symptomatic Recent Onset Persistent AF
Belgium13 participantsStarted 2015-03-03
Plain-language summary
Prospective trial comparing the efficacy and safety of CryoBalloonAblation (CBA) to standardized medication for treatment of early onset persistent atrial fibrillation (AF) without structural heart disease. The value of CBA in these patients has never been studied; the endpoints for persistent patients are much easier than for paroxysmal patients. Reduction in left atrial (LA) size will be compared versus patients on drug therapy and versus failing patients.
Who can participate
Age range
21 Years – 75 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:
* \> 21 years and legally capable
* First documentation or history of symptomatic AF more than 30 sec within the last 2 years
* Twice AF within the last year
* One episode cardioverted after more than 48 hours or spontaneously terminated after more than 7 days
* Eligible for at least one first step drug therapy (sotalol, propafenone, or flecainide) and for amiodarone
* Left ventricular ejection fraction estimated \> 45%
* LA diameter \< 50 mm (parasternal short axis) and LA volume less than 100 ml (apical view, Area Length method;)
* CHADS2 ≤ 2
* Failed AAD strategy, or untreated with AAD
* No use of Amiodarone in the previous 3 months (except IV or oral for 7 days)
* Informed consent
Exclusion Criteria:
* Age \> 75 yrs
* CHF
* Ischemic heart disease as known in the history
* (Severe) Left ventricular hypertrophy as shown on echo (IVSd or PWd \> 14 mm)
* Hyperthyroidism
* Congenital heart disease
* Hypertrophic Cardiomyopathy, Arrhythmogenic Right ventricular Cardiomyopathy, channelopathies
* Contra-indications to AAD
* Long QT syndrome
* Received already adequately dosed all level 1 drugs (sotalol, propafenone, and flecainide)
* Pure (typical) atrial flutter as documented on one occasion
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.