PulseSelect™ PFA Global Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada, China, Croatia, France, Germany +7
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PulseSelect PFA Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform
Overview
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.
Primary outcome measures
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 9 centers
- Fuwai Hospital Chinese Academy of Medical Sciences — Beijing
- Fujian Provincial Hospital — Fuzhou
- The Second Affiliated Hospital of Harbin Medical University — Harbin
- Nanjing Drum Tower Hospital — Nanjing
- Ruijin Hospital Shanghai Jiao Tong University School of Medicine — Shanghai
- Fuwai Shenzhen Hospital Chinese Academy of Medical Sciences — Shenzhen
- The First Affiliated Hospital of Xinjiang Medical University — Ürümqi
- Wuhan Asia General Hospital — Wuhan
- … and 1 more center
France · 5 centers
- Centre Hospitalier Universitaire de Grenoble - Site Nord — Grenoble
- Les Hôpitaux de Chartres - Hôpital Louis Pasteur — Le Coudray
- Hôpital Privé Jacques Cartier — Massy
- Hôpital Européen Georges Pompidou — Paris
- Clinique Pasteur — Toulouse
Germany · 4 centers
- Universitäts Klinikum Frankfurt - Goethe-Universität — Frankfurt
- Universitätsklinikum Heidelberg — Heidelberg
- St. Vincenz Krakenhaus Paderborn — Paderborn
- St. Vincenz-Krankenhaus Paderborn — Paderborn
South Korea · 4 centers
- Seoul National University Bundang Hospital — Seongnam-si
- Seoul National University Hospital — Seoul
- Samsung Medical Center — Seoul
- Severance Hospital — Seoul
Spain · 3 centers
- Hospital Universitario Reina Sofía — Córdoba
- H. Univ. Virgen de la Victoria - Malaga — Málaga
- Complejo Asistencial Universitario de Salamanca — Salamanca
United Kingdom · 3 centers
- Basildon and Thurrock University Hospitals — Basildon
- University Hospitals Coventry & Warwickshire — Coventry
- Saint Georges University Hospitals - NHS Trust — London
Canada · 2 centers
- Vancouver General Hospital — Vancouver
- McGill University Health Centre (MUHC) — Montreal
Croatia · 2 centers
- Klinička Bolnica Dubrava — Zagreb
- Klinički Bolnički Centar Zagreb (KBC) — Zagreb
Italy · 2 centers
- IRCCS Ospedale Sacro Cuore Don Calabria — Negrar
- Azienda Ospedaliera di Ancona — Ancona
Greece · 1 center
- Bioclinic Athens — Athens
Netherlands · 1 center
- St Antonius Ziekenhuis — Nieuwegein
Romania · 1 center
- Spitalul Clinic Județean de Urgență Brașov — Brasov
Identifiers
NCT: NCT06393920 · PulseSelect™ PFA Registry