Recruiting

PULSED AFPULSED AF Post-Approval Study

Sponsor:

Medtronic Cardiac Ablation Solutions

Code:

NCT06578104

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PulseSelect™ PFA system

Study Details

Brief summary:

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.

Conditions

Atrial Fibrillation

Study ID

NCT06578104

Start date

Nov 4, 2024

Status verified date

Feb, 2026

Completion date

Apr 30, 2030

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

580 participants

Anticipated

Interventions and Outcome Measures

Arms

Paroxysmal

Ablation using the PulseSelect™ PFA system

Persistent

Ablation using the PulseSelect™ PFA system

Interventions

PulseSelect™ PFA system

Ablation using the PulseSelect™ PFA system

Primary outcome measure

Efficacy-Freedom from Atrial Fibrillation [ Time Frame: 36-months after the index ablation procedure ]
Safety- Freedom from Device/Procedure Related Adverse Events [ Time Frame: 6 months post-ablation] ]

Central Contacts and Locations

Central contacts

Josman Suri

7635050262 josman.suri@medtronic.com

Locations

University of South Florida Health (USF)

Recruiting

Tampa, Florida, United States, 33606-3603

Contacts

David Wilson

(813) 821-8001 dwilson2@usf.edu

Piedmont Heart Institute

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Reza Karimianpour

4046052800 reza.karimianpour@piedmont.org

Megan Kopp

megan.kopp@piedmont.org

Principal Investigator:

Reza Karimianpour, DO

Endeavor Health Swedish Hospital

Recruiting

Chicago, Illinois, United States, 60625

Contacts

Hany Demo, MD

3472160095 hanydemo@gmail.com

Marisa Durante

8475036454 mdurante@northshore.org

Principal Investigator:

Hany Demo, MD

Pikeville Medical Center

Recruiting

Whitesburg, Kentucky, United States, 41858-7428

Contacts

Joseph Souza, MD

(828) 274-6000 joseph.souza@pikevillehospital.org

Southcoast Health System

Recruiting

Fall River, Massachusetts, United States, 02720

Contacts

Nitesh Sood, MD

soodn@southcoast.org

Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Jason Payne, MD

jason.payne@unmc.edu

The Valley Hospital

Recruiting

New York, New York, United States, 10025

Contacts

Suneet Mittal, MD

(201) 432-7837 mittsu@valleyhealth.com

Northwell Health Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

Contacts

Stavros Mountantonakis, MD

(212) 434-6500 smountanto@northwell.edu

Duke University Medical Center (DUMC)

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Kevin Jackson

(919) 684-8111

Bethesda North Hospital

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Gaurang Gandhi, MD

5137459800 gaurang_gandhi@trihealth.com

Mount Carmel Grove City Medical Center

Recruiting

Grove City, Ohio, United States, 43123

Contacts

Jianqing Li, MD

(614) 627-2000 jianqing.li@mchs.com

Doylestown Health Cardiology a division of Doylestown Health Physicians

Recruiting

Doylestown, Pennsylvania, United States, 18901-2554

Contacts

Robert Sangrigoli, MD

267-893-6800 rsangrigoli@dh.org

AnMed Health Center

Recruiting

Anderson, South Carolina, United States, 29621

Contacts

Rick Henderson, MD

(336) 716-8636 rick.henderson1@anmedhealth.org

Medical University of South Carolina (MUSC)

Recruiting

Charleston, South Carolina, United States, 29425-8908

Contacts

Rachel Kaplan, MD

8437922300 kaplanra@musc.edu

University of Virginia Medical Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Michael Mangrum, MD

(434) 924-3817 jmm5v@virginia.edu

Confluence Health Hospital Central Campus

Recruiting

Wenatchee, Washington, United States, 98801

Contacts

Roy Lin, MD

9172949832 roy.lin@confluencehealth.org

Principal Investigator:

Roy Lin, MD

London Health Sciences Centre - University Campus

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Habib Khan

5196633746 habib.khan@lhsc.on.ca

Principal Investigator:

Habib Khan

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada

Contacts

Sheldon Singh

4164806100 sheldon.singh@sunnybrook.ca

Principal Investigator:

Sheldon Singh

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Contacts

Katia Dyrda, MD

5143763330 katia.dyrda@umontreal.ca

Principal Investigator:

Katia Dyrda, MD

More Information

Sponsor

Medtronic Cardiac Ablation Solutions

Last update posted

Aug 12, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medtronic Cardiac Ablation Solutions on 2026-08-12.