aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibr… (NCT02513797) | Clinical Trial Compass
UnknownNot Applicable
aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation
United States600 participantsStarted 2015-09
Plain-language summary
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation.
This study will be conducted in two stages:
* Limited Early Stage (Stage 1): up to 250 subjects at up to 65 sites. (COMPLETED, transitioned to Stage 2)
* Pivotal Stage/ Phase III (Stage 2): up to 600 subjects at up to 65 sites. (COMPLETED) All subjects from both stages will be included in the primary analysis.
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:
* Documented diagnosis of symptomatic continuous persistent or longstanding persistent non-valvular atrial fibrillation
* Failed at least one Class I or III Antiarrythmic drug (AAD) and therefore, eligible and intended for standard of care catheter 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:
* Prior procedure involving opening of the pericardium or entering the pericardial space (e.g., coronary artery bypass graft, heart transplantation, valve surgery) where adhesions are suspected;
* Any prior epicardial ablation or any type of left-sided atrial ablation procedure;
* LA diameter \> 6 cm as measured by computerized tomography and confirmed by the imaging core laboratory;
* Documented embolic stroke, transient ischemic attach or suspected neurologic event within 3 months prior to the planned study intervention;
* Currently exhibits New York Heart Association 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;
* Documented history of cardiogenic shock, hemodynamic instability or any medical condition in wh…
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 atrial fibrillation > 30 seconds at 12 months post index pulmonary vein isolation
Timeframe: 12 months following Pulmonary Vein Isolation catheter ablation procedure