Subxyphoid Hybrid MAZE Registry for Patients With Persistent Atrial Fibrillation

Enrolling by invitation

Conditions studied: Atrial Fibrillation, Persistent

In brief

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.

Key facts

Study ID

NCT04148625

Run by

University of California, San Francisco

People needed

100

Starts

2016-09-14

Expected to finish

2026-06-30

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following criteria to be eligible for the study:
• Age ≥ 18 years and ≤ 80 years at time of screening.
• Documented diagnosis of symptomatic persistent or persistent longstanding non-valvular atrial fibrillation
• Persistent AF is defined as atrial fibrillation sustained for ≥ 7 days and ≤ 1 year;
• Longstanding persistent AF is defined as continuous atrial fibrillation > 1 year duration;
• Non-valvular atrial fibrillation is defined as cases without a mechanical heart valve requiring anticoagulation or without moderate to severe mitral stenosis.
• Note: Persistent AF and Longstanding Persistent AF must be documented as follows:
• Persistent AF:
• Physician's note indicating that patient has experienced symptomatic continuous AF that is sustained ≥ 7 days duration and < 1 year and clinical history of non-paroxysmal AF < 3 years; and
• A ≥7-day continuous rhythm monitoring (e.g., Zio patch, implantable loop recorder (ILR), pacemaker) which documents 90% AF burden over at least 7 consecutive days or alternatively, two electrocardiograms from any form of rhythm monitoring (e.g. 12-lead ECG, Holter, event monitor) documenting continuous AF, with electrocardiograms taken at least 7 days apart, for subjects with sustained AF ≥ 7 days, as confirmed by the ECG Core Laboratory, obtained within 90 days prior to randomization.
• Longstanding Persistent AF:
• Physician's note indicating that patient has experienced symptomatic continuous AF that is sustained > 1 year duration and clinical history of non-paroxysmal AF < 3 years; and
• A ≥7-day continuous rhythm monitoring (e.g., Zio patch, ILR, pacemaker) which documents 90% AF burden over at least 7 consecutive days or alternatively, 24 hour continuous rhythm monitoring (e.g. holter, event monitor) obtained within 90 days prior to the index procedure showing continuous AF, as confirmed by the ECG Core Laboratory. Note: The performance of a successful cardioversion (sinus rhythm ≥30 seconds) within 12 months of an ablation procedure with documented early recurrence of AF within 30 days should not alter the classification of AF as Longstanding Persistent.)
• 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

You may not qualify if…

• Exclusion Criteria: Subjects will be excluded if he / she meets any of the following:
• 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;
• Documented symptomatic carotid disease, defined as > 70% stenosis or > 50% stenosis with symptoms;
• Diagnosed active local or systemic infection, septicemia or fever of unknown origin at time of baseline screening;
• Chronic renal insufficiency defined as estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 within 3 months prior to study treatment;
• End Stage Renal Disease (ESRD) or documented history of renal replacement / dialysis;
• Current documented history of clinically significant liver disease which predisposes the subject to significant bleeding risk (clinically defined by the treating physician);
• Any history or thoracic radiation with the exception of localized radiation treatment for breast cancer;
• Current documented use of long-term treatment with corticoid steroids, not including use of inhaled steroids for respiratory diseases;
• Active pericarditis;
• Active endocarditis;
• Any documented history or autoimmune disease associated with pericarditis;
• Evidence of Pectus Excavatum (documented and clinically defined by the treating physician);
• Untreated severe scoliosis (documented and clinically defined by treating physician);
• Thrombocytopenia (platelet count < 100 x 109/L) based on most recent pre-procedure assessment within 30 days prior to planned intervention;
• Anemia with hemoglobin concentration of <8 g/dL based on most recent pre-procedure assessment (within 30 days prior to planned intervention);
• Left Ventricular Ejection Fraction (LVEF) < 30% within 30 days prior to planned intervention;
• Known acquired or inherited propensity for forming blood clots (e.g., malignancy, Factor V leiden mutation) established by prior objective testing;

Full record on ClinicalTrials.gov

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