PulseSelect™ PFA Global Registry

PulseSelect PFA Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06393920

Enrollment

1950

Registered

2024-05-01

Start date

2024-07-23

Completion date

2028-07-31

Last updated

2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Detailed description

The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to collect clinical performance and safety data in a broad patient population treated with the PulseSelect™ PFA system. The PulseSelect™ PFA System used in the study is market approved. The ablation procedure will be performed according to routine hospital practice. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy-Freedom from Atrial Fibrillation	≥ 91 days after the index ablation procedure	Estimate the freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.
Safety- Freedom from Device/Procedure Related Adverse Events	Within 6 months post-ablation	Estimate serious device and serious procedure-related adverse events for the PulseSelect™ PFA system

Countries

Belgium, Canada, China, Croatia, France, Germany, Greece, Italy, Netherlands, New Zealand, Romania, Slovenia, South Korea, Spain, United Kingdom

Contacts

CONTACTJosman Suri

josman.suri@medtronic.com7635050262

STUDY_DIRECTORKhaldoun Tarakji, MD

Medtronic CAS Chief Medical Officer

Outcome results