TerminatedNot Applicable

Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation

Stopped: Prematurely closed due to ongoing challenging enrollment requirements.

Germany, Israel, Italy17 participantsStarted 2011-11

Plain-language summary

Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial Fibrillation (AF) with the Cardioblate CryoFlex Surgical Ablation System. The system is approved and commercially available with CE mark. The purpose of this study is to support clinical evidence that the Cardioblate System is safe and effective to treat AF.

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: * Patients must have a documented history of longstanding persistent AF as defined by the HRS/EHRA/ECAS Guidelines * Patients should have a concomitant indication (other than AF) for open-heart surgery for mitral valve repair or replacement (bioprosthesis) * Patients should be older than or equal to 18 years of age Exclusion Criteria: * Atrioventricular reentrant tachycardia (AVRT) * NYHA Class = IV * Left ejection fraction of ≤ 30% * Need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery * Previous atrial fibrillation ablation, AV-nodal ablation, or surgical Maze procedure * Contraindication for anticoagulation therapy * Left atrial diameter \> 7.0 cm * Preoperative need for intra-aortic balloon pump or intravenous inotropes * Renal failure requiring dialysis or hepatic failure * Life expectancy of less than one year * Pregnancy or desire to be pregnant within 12 months of the study treatment * Current diagnosis of active systemic infection * Documented MI 6 weeks prior to study enrollment

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

Efficacy: Percentage of Treated Subjects Diagnosed With Longstanding Persistent AF Off Class I or III Antiarrhythmic Drugs and Out of AF at 12 Months, and Who Did Not Receive Additional Ablation Therapy for AF Prior to the 12-month Evaluation.

Timeframe: 12 months

Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last

Timeframe: 30 days

Trial details

NCT IDNCT01558635

SponsorMedtronic Cardiac Rhythm and Heart Failure

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-01

Results submitted2018-02-19

View on ClinicalTrials.gov More Longstanding Persistent Atrial Fibrillation trials