PULSED AF Post-Approval Study

August 11, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London Health Sciences Centre - University Campus
        • Principal Investigator:
          • Habib Khan
        • Contact:
      • Toronto, Ontario, Canada
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Sheldon Singh
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Recruiting
        • Montreal Heart Institute
        • Principal Investigator:
          • Katia Dyrda, MD
        • Contact:
  • South Korea
      • Daegu, South Korea, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital
        • Contact:
        • Principal Investigator:
          • Hyoung Seob Park, MD
  • 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
        • Active, not recruiting
        • The Ohio State University Wexner Medical Center
      • 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
        • Active, not recruiting
        • Texas Health Research & Education Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Medical Center
        • Contact:
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Recruiting
        • Confluence Health Hospital Central Campus
        • Contact:
        • Principal Investigator:
          • Roy Lin, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Ablation Solutions

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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