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 range18 Years – 80 Years
SexALL
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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
✕. 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;
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
. 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;