Clinical trial NCT06393920: PulseSelect™ PFA Global Registry
Official title: PulseSelect PFA Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy-Freedom from Atrial Fibrillation
timeFrame: ≥ 91 days after the index ablation procedure
measure: Safety- Freedom from Device/Procedure Related Adverse Events
timeFrame: Within 6 months post-ablation
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC)
state: Quebec
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Grenoble - Site Nord
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Hamburg
country: Germany
facility: Asklepios Klinik St Georg
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus Paderborn
city: Negrar Di Valpolicella
country: Italy
facility: IRCCS Ospedale Sacro Cuore Don Calabria
state: Verona
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
city: Lódź
country: Poland
facility: Centralny Szpital Kliniczny Uniwersytetu Medyczneg
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca
city: Basildon
country: United Kingdom
facility: Basildon and Thurrock University Hospitals
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry & Warwickshire
Study officials:
affiliation: Medtronic CAS Chief Medical Officer
name: Khaldoun Tarakji, MD
role: STUDY_DIRECTOR
References: