Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fi… (NCT06557616) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Efficacy of the CoolCryo System for Cardiac Cryoablation in the Treatment of Atrial Fibrillation
Poland20 participantsStarted 2024-07-03
Plain-language summary
The study involves endocardial cryoablation of the left and/or right atrium of the heart using the CoolCryo system as an adjunct to mitral valve surgery, with the aim of eliminating atrial fibrillation (AF), which is a common sequelae of mitral valve defects and is associated with an increased risk of ischaemic stroke, heart failure and death.
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
. Written consent from the patient to participate in the study.
. age ≥18 years.
. patient qualified for mitral valve surgery (mitral valve plication or mitral valve replacement "with" or "without" left atrial appendage closure).
Exclusion criteria
. Lack of written consent from the patient to participate in the study.
. Failure to meet the inclusion criteria.
. Contraindications to the cryoablation procedure.
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
Percentage of patients with no documented recurrence of atrial fibrillation on continuous 48h Holter ECG recording during 6-month follow-up.
Timeframe: 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure
2
Incidence of adverse events and serious adverse events related to the use of the
Timeframe: 6 day (+/- 1 day), 12 weeks (+/- 7 days) and 25 weeks (+/- 7 days) after the procedure
. Patient breastfeeding, pregnant or planning pregnancy within 6 months of study treatment.
. co-morbidities and/or conditions that may cause atrial fibrillation (uncompensated hyperthyroidism or hypothyroidism, acute infection, pheochromocytoma, significant dyselectrolitemia).
. significant calcification of the left atrium.
. Condition after previous cardiac surgery.
. significant left atrial enlargement (size greater than 10 cm on echocardiography in one of the projections performed). projection).