Atrial FibrillationNCT06578104
PULSED AF Post-Approval Study
An observational study of Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 23 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- PulseSelect™ PFA system
- Type of treatment
- Medical device
- How many people
- 580 participants
- Where
- 23 sitesin 3 countries
- Study dates
- 4 Nov 2024to 30 Apr 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 3 countries
United States19 sites, 15 recruiting
- Recruiting
AnMed Health Center
Anderson, South Carolina, 29621
Rick Henderson, MD, (336) 716-8636, rick.henderson1@anmedhealth.org
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309
Reza Karimianpour, 4046052800, reza.karimianpour@piedmont.org
Megan Kopp, megan.kopp@piedmont.org
- Recruiting
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425-8908
Rachel Kaplan, MD, 8437922300, kaplanra@musc.edu
- Recruiting
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Michael Mangrum, MD, (434) 924-3817, jmm5v@virginia.edu
- Recruiting
Endeavor Health Swedish Hospital
Chicago, Illinois, 60625
Hany Demo, MD, 3472160095, hanydemo@gmail.com
Marisa Durante, 8475036454, mdurante@northshore.org
- Recruiting
Bethesda North Hospital
Cincinnati, Ohio, 45220
Gaurang Gandhi, MD, 5137459800, gaurang_gandhi@trihealth.com
- Terminated
The Ohio State University Wexner Medical Center
Columbus, Ohio, 045218
- Active, not recruiting
Texas Health Research & Education Institute
Dallas, Texas, 75231-3815
- Recruiting
Doylestown Health Cardiology a division of Doylestown Health Physicians
Doylestown, Pennsylvania, 18901-2554
Robert Sangrigoli, MD, 267-893-6800, rsangrigoli@dh.org
- Recruiting
Duke University Medical Center (DUMC)
Durham, North Carolina, 27710
Kevin Jackson, (919) 684-8111
- Recruiting
Southcoast Health System
Fall River, Massachusetts, 02720
Nitesh Sood, MD, soodn@southcoast.org
- Recruiting
Mount Carmel Grove City Medical Center
Grove City, Ohio, 43123
Jianqing Li, MD, (614) 627-2000, jianqing.li@mchs.com
- Recruiting
The Valley Hospital
New York, New York, 10025
Suneet Mittal, MD, (201) 432-7837, mittsu@valleyhealth.com
- Recruiting
Northwell Health Lenox Hill Hospital
New York, New York, 10075
Stavros Mountantonakis, MD, (212) 434-6500, smountanto@northwell.edu
- Recruiting
Nebraska Medical Center
Omaha, Nebraska, 68198
Jason Payne, MD, jason.payne@unmc.edu
- Withdrawn
Beaumont Health System
Royal Oak, Michigan, 48073
- Terminated
University of South Florida Health (USF)
Tampa, Florida, 33606-3603
- Recruiting
Confluence Health Hospital Central Campus
Wenatchee, Washington, 98801
Roy Lin, MD, 9172949832, roy.lin@confluencehealth.org
Roy Lin, MD
- Recruiting
Pikeville Medical Center
Whitesburg, Kentucky, 41858-7428
Joseph Souza, MD, (828) 274-6000, joseph.souza@pikevillehospital.org
Canada3 sites, 3 recruiting
- Recruiting
London Health Sciences Centre - University Campus
London, Ontario, N6A 5A5
Habib Khan, 5196633746, habib.khan@lhsc.on.ca
Habib Khan
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Katia Dyrda, MD, 5143763330, katia.dyrda@umontreal.ca
Katia Dyrda, MD
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
Sheldon Singh, 4164806100, sheldon.singh@sunnybrook.ca
Sheldon Singh
South Korea1 site, 1 recruiting
- Recruiting
Keimyung University Dongsan Hospital
Daegu, 42601
Hyoung Seob Park, MD, +82 532507407, drparkgyver@gmail.com
Hyoung Seob Park, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- PulseSelect™ PFA system
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulseSelect™ PFA systemDevice
Ablation using the PulseSelect™ PFA system
| Study group | Role | What they receive |
|---|---|---|
| Paroxysmal | Ablation using the PulseSelect™ PFA system Receives: Device: PulseSelect™ PFA system | |
| Persistent | Ablation using the PulseSelect™ PFA system Receives: Device: PulseSelect™ PFA system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy-Freedom from Atrial Fibrillation
Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.
Measured: 36-months after the index ablation procedure
Safety- Freedom from Device/Procedure Related Adverse Events
Estimate the rate of major procedural complications for catheter ablation using PulseSelect™ PFA system.
Measured: 6 months post-ablation]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start4 Nov 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khaldoun Tarakji, MD, Study director, Medtronic CAS Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578104
- Sponsor's protocol ID
- PULSED AF PAS
- Status last verified
- Feb 2026
- First submitted
- 27 Aug 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry
- ClinicalTrials.gov ID
- NCT06578104
- Acronym / sponsor ID
- PULSED AF PAS
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paroxysmal | – | Device: PulseSelect™ PFA systemAblation using the PulseSelect™ PFA system |
| Persistent | – | Device: PulseSelect™ PFA systemAblation using the PulseSelect™ PFA system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PulseSelect™ PFA systemAblation using the PulseSelect™ PFA system | Device | Paroxysmal, Persistent |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khaldoun Tarakji, MD study director
Medtronic CAS Chief Medical Officer
23 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 23 sites in 3 countries.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Josman Suri (7635050262, josman.suri@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy-Freedom from Atrial Fibrillation (time frame: 36-months after the index ablation procedure). 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?
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 28 Oct 2026.