Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
NCT ID: NCT06099730
Last Updated: 2025-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
360 participants
INTERVENTIONAL
2023-12-14
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pulsed Field Ablation
This is a non-randomized one arm study.
Pulsed Field Ablation (PFA)
PFA using Irreversible Electroporation (IRE) Ablation System
Interventions
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Pulsed Field Ablation (PFA)
PFA using Irreversible Electroporation (IRE) Ablation System
Eligibility Criteria
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Inclusion Criteria
* Age 18-80 years
* Willing and capable of providing written consent
* Able and willing to comply with all pre-, post- and follow-up testing and requirements.
Exclusion Criteria
* Documented LA thrombus by imaging within 48 hours before procedure (CT, TEE, or intracardiac echocardiogram at the beginning of the procedure).
* Uncontrolled heart failure or New York Heart Association (NYHA) Class IV
* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the PFA energy field
* Women who are pregnant (as evidenced by pregnancy test if pre- menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
* Life expectancy less than 12 months
* Currently enrolled in an investigational study evaluating another device, biologic, or drug that would interfere with this trial
18 Years
80 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Moussa C Mansour
PI
Locations
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St. Bernard's Heart and Vascular Center
Jonesboro, Arkansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mount Sinai Hospital
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Texas Cardiac Arrhythmia Institute/Research Foundation
Austin, Texas, United States
Countries
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Other Identifiers
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2023P002605
Identifier Type: -
Identifier Source: org_study_id
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