Subxyphoid Hybrid MAZE Registry for Patients With Persistent Atrial Fibrillation

NCT04148625 | Enrolling By Invitation

• 1 other identifier: 19-29483
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrial Fibrillation, Persistent

Keywords

hybrid, LAA ligation

Outcome Measures

Primary Outcomes (2)

• Freedom from episodes of AF > 30 seconds

  * No evidence of any episode of AF/AT/AFL \> 30 seconds duration, as documented by 24 hour holter monitoring at any time following the 90-day blanking period post index PVI at 6 and 12 months; and/or if patient has symptoms of palpitations. * No additional catheter ablation procedures post index PVI (aside from ablation for right-sided AFL) * No requirement for new Class I or III anti-arrhythmic drug (AAD) prescribed to treat atrial fibrillation following day 120 (90 day blanking period + 30 day window).

  12 months

• 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.

  • Serious injury to cardiac/ related structure requiring surgical intervention• Bleeding• Pericarditis requiring surgical treatment• Hemothorax requiring surgical treatment

  30 days after hybrid procedure• Pneumothorax requiring surgical treatment • Vascular Injury requiring surgical treatment

Study Arms (1)

atrial fibrillation, persistent

Subjects with documented symptomatic persistent or longstanding persistent AF (\> than 3 months and \< 3 years continuous AF duration) who has failed a previous PVI catheter ablation procedure and/or needs LAA exclusion; and catheter ablation or minimally surgical approach is planned.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with documented symptomatic persistent or longstanding persistent AF (\> than 3 months and \< 3 years continuous AF duration) who has failed a previous PVI catheter ablation procedure and/or needs LAA exclusion; and catheter ablation or minimally surgical approach is planned.

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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of California, San Francisco: lead
• Stanford University: collaborator
• Vanderbilt University Medical Center: collaborator

Related Publications (2)

• Badhwar N, Al-Dosari G, Dukes J, Lee RJ. Subxiphoid Hybrid Approach for Epicardial/Endocardial Ablation and LAA Exclusion in Patients with Persistent and Longstanding Atrial Fibrillation. J Atr Fibrillation. 2018 Jun 30;11(1):2014. doi: 10.4022/jafib.2014. eCollection 2018 Jun-Jul.

  PMID: 30455837 RESULT

• Sanchez JM, Al-Dosari G, Chu S, Beygui R, Deuse T, Badhwar N, Lee RJ. Hybrid and surgical procedures for the treatment of persistent and longstanding persistent atrial fibrillation. Expert Rev Cardiovasc Ther. 2018 Feb;16(2):91-97. doi: 10.1080/14779072.2018.1425140. Epub 2018 Jan 12.

  PMID: 29327638 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Randall J Lee, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: September 14, 2016
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share