Recruiting

PulseSelect™ PFA

Sponsor:

Medtronic Cardiac Ablation Solutions

Code:

NCT06393920

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.

Conditions

Atrial Fibrillation

Study ID

NCT06393920

Start date

Jul 23, 2024

Status verified date

Feb, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject is ≥ 18 years of age or minimum age as required by local regulations.
  • Subject has been diagnosed with atrial fibrillation (AF)
  • Planned procedure using commercially available PulseSelect™ PFA System.
  • Willing 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:

  • Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.
  • Subject with exclusion criteria required by local law.

Study Design

Enrollment

1950 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Efficacy-Freedom from Atrial Fibrillation [ Time Frame: ≥ 91 days after the index ablation procedure ]
  • Safety- Freedom from Device/Procedure Related Adverse Events [ Time Frame: Within 6 months post-ablation ]

Central Contacts and Locations

Central contacts

Josman Suri

7635050262josman.suri@medtronic.com

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Jason Andrade, MD

(778) 558-5813jason.andrade@vch.ca

McGill University Health Centre (MUHC)

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

Atul Verma, MD

(514) 934-1934atul.verma@mcgill.ca

More Information

Sponsor

Medtronic Cardiac Ablation Solutions

Last update posted

May 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medtronic Cardiac Ablation Solutions on 2026-05-27.