Clinical Trials in Australia / NCT06393920
Recruiting
Observational
PulseSelect™ PFA Global Registry
NCT06393920 · tracked via the Priya Life Science Australia tracker
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
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 |
|---|---|---|---|
| Epworth Richmond | Richmond | Victoria | Recruiting |
| 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 | Active Not Recruiting |
| Fujian Provincial Hospital | Fuzhou | China | Active Not Recruiting |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | China | Active Not Recruiting |
| The First Peoples Hospital of Yunnan Province | Kunming | China | Active Not Recruiting |
| Nanjing Drum Tower Hospital | Nanjing | China | Active Not 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 | Active Not Recruiting |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | China | Active Not Recruiting |
| Wuhan Asia General Hospital | Wuhan | China | Active Not Recruiting |
| The First Affiliated Hospital of Xiamen University | Xiamen | China | Active Not Recruiting |
| Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College | Zhengzhou | China | Active Not Recruiting |
| Klinička Bolnica Dubrava | Zagreb | Croatia | Active Not Recruiting |
| Klinički Bolnički Centar Zagreb (KBC) | Zagreb | Croatia | Active Not 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 | Active Not 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 |
+ 3 more sites — see the full list on the official registry below.
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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 Australia