PulseSelect™ PFA Global Registry

NCT06393920 · tracked via the Priya Life Science UK tracker

Sponsor

Medtronic Cardiac Ablation Solutions

Phase

Observational

Started

2024-07-23

Last updated

2026-08-13

Condition(s) studied

Atrial Fibrillation

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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 exclusion criteria required by local law.

Primary outcome measure(s)

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

Trial sites (43)

Facility	City	Region	Status
Jessa Ziekenhuis	Hasselt	Belgium	Active Not Recruiting
Vancouver General Hospital	Vancouver	British Columbia	Active Not Recruiting
McGill University Health Centre (MUHC)	Montreal	Quebec	Active Not Recruiting
Fuwai Hospital Chinese Academy of Medical Sciences	Beijing	China	Recruiting
Fujian Provincial Hospital	Fuzhou	China	Recruiting
The Second Affiliated Hospital of Harbin Medical University	Harbin	China	Recruiting
The First Peoples Hospital of Yunnan Province	Kunming	China	Recruiting
Nanjing Drum Tower Hospital	Nanjing	China	Recruiting
Ruijin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	China	Active Not Recruiting
Fuwai Shenzhen Hospital Chinese Academy of Medical Sciences	Shenzhen	China	Recruiting
The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	China	Active Not Recruiting
Wuhan Asia General Hospital	Wuhan	China	Recruiting
The First Affiliated Hospital of Xiamen University	Xiamen	China	Recruiting
Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College	Zhengzhou	China	Recruiting
Klinička Bolnica Dubrava	Zagreb	Croatia	Active Not Recruiting
Klinički Bolnički Centar Zagreb (KBC)	Zagreb	Croatia	Recruiting
Centre Hospitalier Universitaire de Grenoble - Site Nord	Grenoble	France	Active Not Recruiting
Les Hôpitaux de Chartres - Hôpital Louis Pasteur	Le Coudray	France	Active Not Recruiting
Hôpital Privé Jacques Cartier	Massy	France	Active Not Recruiting
Hôpital Européen Georges Pompidou	Paris	France	Active Not Recruiting
Clinique Pasteur	Toulouse	France	Active Not Recruiting
Universitäts Klinikum Frankfurt - Goethe-Universität	Frankfurt	Germany	Active Not Recruiting
Universitätsklinikum Heidelberg	Heidelberg	Germany	Active Not Recruiting
Klinikum der Stadt Ludwigshafen	Ludwigshafen am Rhein	Germany	Active Not Recruiting
St. Vincenz Krakenhaus Paderborn	Paderborn	Germany	Active Not Recruiting
St. Vincenz-Krankenhaus Paderborn	Paderborn	Germany	Recruiting
Bioclinic Athens	Athens	Greece	Active Not Recruiting
IRCCS Ospedale Sacro Cuore Don Calabria	Negrar	Verona	Active Not Recruiting
Azienda Ospedaliera di Ancona	Ancona	Italy	Active Not Recruiting
St Antonius Ziekenhuis	Nieuwegein	Netherlands	Active Not Recruiting
Auckland Hospital	Auckland	New Zealand	Recruiting
Spitalul Clinic Județean de Urgență Brașov	Brasov	Romania	Active Not Recruiting
University Medical Centre Ljubljana	Ljubljana	Slovenia	Active Not Recruiting
Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Active Not Recruiting
Seoul National University Hospital	Seoul	Seoul	Active Not Recruiting
Samsung Medical Center	Seoul	South Korea	Active Not Recruiting
Severance Hospital	Seoul	South Korea	Active Not Recruiting
Hospital Universitario Reina Sofía	Córdoba	Spain	Active Not Recruiting
H. Univ. Virgen de la Victoria - Malaga	Málaga	Spain	Active Not Recruiting
Complejo Asistencial Universitario de Salamanca	Salamanca	Spain	Active Not Recruiting

+ 3 more sites — see the full list on the official registry below.

Other trials for the same condition

Affera Global Registry Recruiting

CHAMPION-AF Clinical Trial Active, not recruiting

A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation Active, not recruiting

Amplatzer Amulet LAAO vs. NOAC Active, not recruiting

Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06393920 on ClinicalTrials.gov ↗ ← All trials in the UK