Subxyphoid Hybrid MAZE Registry for Patients With Persistent Atrial Fibrillation (NCT04148625) | Clinical Trial Compass
By InvitationNot Applicable
Subxyphoid Hybrid MAZE Registry for Patients With Persistent Atrial Fibrillation
100 participantsStarted 2016-09-14
Plain-language summary
Minimally invasive surgical procedures have been advocated as an alternative to catheter ablation for the treatment of persistent atrial fibrillation. Initial results have been promising in maintaining sinus rhythm compared to catheter ablation, but are associated with a considerably greater number of procedural-related adverse events compared to catheter ablation. This study investigates the safety and feasibility of a new subxyphoid epicardial/endocardial hybrid atrial fibrillation ablation and LAA exclusion approach for patients with persistent and longstanding persistent atrial fibrillation.
Who can participate
Age range
18 Years – 80 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
. Age ≥ 18 years and ≤ 80 years at time of screening.
. Documented diagnosis of symptomatic persistent or persistent longstanding non-valvular atrial fibrillation
. Failed previous catheter PVI ablation
. Life expectancy ≥ 1 year;
. Willing and able to return to and comply with scheduled follow-up visits and tests; and
. Willing and able to provide written informed consent
Exclusion criteria
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
Freedom from episodes of AF > 30 seconds
Timeframe: 12 months
2
The incidence of adjudicated significant device- or procedure-related SAEs • Pericardial effusions requiring surgical intervention occurring within 30 days after the hybrid sub-X MAZE procedure.
Timeframe: 30 days after hybrid procedure• Pneumothorax requiring surgical treatment • Vascular Injury requiring surgical treatment
. Prior procedure involving opening of the pericardium or entering the pericardial space (e.g., coronary artery bypass graft (CABG), heart transplantation, valve surgery) where adhesions are suspected;
. Measured LA diameter \> 6.5 cm;
. Documented embolic stroke, Transient ischemic attack (TIA) or suspected neurologic event within 3 months prior to the planned intervention;
. Currently exhibits New York Heart Association (NYHA) Class IV heart failure symptoms;
. Documented history of right heart failure specifically when right ventricle exceeds the left ventricular size;
. Documented history of myocardial infarction (MI) within 3 months prior to the planned study intervention;
. Documented history of unstable angina within 3 months prior to the planned study intervention;
. Recent documented history of cardiogenic shock, hemodynamic instability or any medical condition in which intra-aortic balloon pump (IABP) therapy is clinically indicated;