PULSED AF Post-Approval Study

May 22, 2026 updated by: Medtronic Cardiac Ablation Solutions

PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry

PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PulseSelect is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months. Study visits will occur at 3, 6, 12, 24, and 36 months post-ablation, including required 24-hour Holter monitoring at 6, 12, 24, and 36 month visits. The PulseSelect™ PFA System used in this study is market approved and the ablation procedure will be performed according to hospital standard of care.

Study Type

Observational

Enrollment (Estimated)

580

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606-3603
        • Recruiting
        • University of South Florida Health (USF)
        • Contact:
    • Georgia
    • Illinois
      • Chicago, Illinois, United States, 60625
        • Recruiting
        • Endeavor Health Swedish Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hany Demo, MD
    • Kentucky
      • Whitesburg, Kentucky, United States, 41858-7428
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Withdrawn
        • Beaumont Health System
    • Nebraska
      • Omaha, Nebraska, United States, 68198
    • New York
      • New York, New York, United States, 10075
        • Recruiting
        • Northwell Health Lenox Hill Hospital
        • Contact:
      • New York, New York, United States, 10025
        • Recruiting
        • The Valley Hospital
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center (DUMC)
        • Contact:
          • Kevin Jackson
          • Phone Number: (919) 684-8111
    • Ohio
      • Cincinnati, Ohio, United States, 45220
      • Columbus, Ohio, United States, 045218
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:
      • Grove City, Ohio, United States, 43123
        • Recruiting
        • Mount Carmel Grove City Medical Center
        • Contact:
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901-2554
        • Recruiting
        • Doylestown Health Cardiology a division of Doylestown Health Physicians
        • Contact:
    • South Carolina
      • Anderson, South Carolina, United States, 29621
      • Charleston, South Carolina, United States, 29425-8908
        • Recruiting
        • Medical University of South Carolina (MUSC)
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75231-3815
        • Recruiting
        • Texas Health Research & Education Institute
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System

Description

Inclusion Criteria

  • A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF
  • Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)
  • Patient is ≥ 18 years of age
  • Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System
  • Willing and able to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements

Exclusion Criteria

  • Long-standing persistent AF (continuous AF sustained >12 months)
  • Prior left atrial catheter or surgical ablation
  • Patient with life expectancy < 36 months
  • Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
  • Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Paroxysmal
Ablation using the PulseSelect™ PFA system
Device: PulseSelect™ PFA system
Ablation using the PulseSelect™ PFA system
Persistent
Ablation using the PulseSelect™ PFA system
Device: PulseSelect™ PFA system
Ablation using the PulseSelect™ PFA system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy-Freedom from Atrial Fibrillation
Time Frame: 36-months after the index ablation procedure
Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.
36-months after the index ablation procedure
Safety- Freedom from Device/Procedure Related Adverse Events
Time Frame: 6 months post-ablation]
Estimate the rate of major procedural complications for catheter ablation using PulseSelect™ PFA system.
6 months post-ablation]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Ablation Solutions

Investigators

  • Study Director: Khaldoun Tarakji, MD, Medtronic CAS Chief Medical Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PULSED AF PAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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