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Atrial Fibrillation, PersistentSubXMAZENCT04148625

Subxyphoid Hybrid MAZE Registry for Patients With Persistent Atrial Fibrillation

An observational study of Atrial Fibrillation, Persistent, run by University of California, San Francisco.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atrial Fibrillation, Persistent
How many people
100 participants
Where
No sites listed yet
Study dates
14 Sep 2016to 30 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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;
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  • 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;
  • Documented presence of implanted congenital defect closure devices, (e.g., atrial septal device (ASD), patent foramen vale (PFO) or ventricular septal device (VSD) device);
  • Previously attempted occlusion of the LAA (by any surgical or percutaneous method);
  • Inability, unwillingness or contraindication to undergo TEE imaging;
  • Body Mass Index (BMI) > 40;
  • Evidence of active Graves disease;
  • Current untreated hypothyroidism;
  • Any contraindication to suture, endovascular device, or other minimally invasive techniques including percutaneous, transseptal, and/or sub-xiphoid access.
  • Subject is pregnant or plans / desires to get pregnant within next 12 months;
  • Current enrollment in an investigation or study of an investigational device or investigational drug that would interfere with this study and the required follow up;
  • Mental impairment or other psychiatric conditions which may not allow patient to understand the nature, significance and scope of the study;
  • Any other criteria, medical illness or comorbidity which would make the subject unsuitable to participate in this study as determined by the clinical site Primary Investigator; Additional Exclusion Criteria: Based on Screening / Pre-procedure Imaging
  • Subjects will also be excluded if they meet any of the following:
  • Based on screening computed tomography angiography (CTA) performed prior to study intervention:
  • LAA Morphology: Superior-posterior oriented LAA (i.e. superior C shape), that has:
  • LAA LARIAT-approach width ≥ 40 mm; or
  • LAA distal apex extending posterior to the ostium of the LAA.
  • LAA positioned behind the pulmonary artery; or
  • All other LAA morphology: LAA LARIAT approach width > 45 mm.
  • Based on a peri-procedural imaging (TEE at time of hybrid sub-X MAZE procedure. or catheter ablation):
  • Intracardiac thrombus; or
  • Significant mitral valve stenosis (i.e., mitral valve (MV) stenosis < 1.5cm2)

About this study

Official title: Subxyphoid Epicardial/Endocardial Hybrid Atrial Fibrillation Ablation and Left Atrial Appendage (LAA) Exclusion Approach for Patients With Persistent and Longstanding Persistent Atrial Fibrillation Registry

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.

Read the detailed description

The study will assess the ability of a subxyphoid and percutaneous hybrid epicardial/endocardial ablation approach consisting of pulmonary vein isolation (PVI), LAA exclusion, isolation of the left atrial (LA) posterior wall and cavotricuspid isthmus (CTI) line (Hybrid Sub-X MAZE) to (1) demonstrate that the hybrid procedure does not result in an unacceptable risk of serious adverse events (SAEs) in persistent or longstanding persistent atrial fibrillation (AF) subjects for whom an ablation procedure is planned; and (2) assess freedom from episodes of persistent AF > 30 seconds duration during the observation period through 12 months post PVI.

Keywords
hybrid, LAA ligation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04148625
Study groupRoleWhat they receive
atrial fibrillation, persistentSubjects 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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.

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2019
  2. Study start14 Sep 2016
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04148625
Sponsor's protocol ID
19-29483
Acronym
SubXMAZE
Status last verified
Apr 2026
First submitted
30 Oct 2019
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30455837

  • 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.

    PubMed 29327638

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, Persistent, run by University of California, San Francisco.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from episodes of AF > 30 seconds (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04148625, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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