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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy-Freedom from Atrial Fibrillation | Estimate the freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system. | ≥ 91 days after the index ablation procedure |
| Safety- Freedom from Device/Procedure Related Adverse Events | Estimate serious device and serious procedure-related adverse events for the PulseSelect™ PFA system | Within 6 months post-ablation |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josman Suri | Contact | 7635050262 | josman.suri@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Khaldoun Tarakji, MD | Medtronic CAS Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
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| McGill University Health Centre (MUHC) | Recruiting | Montreal | Quebec | H3G 1A4 | Canada |
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| Fuwai Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | 100037 | China |
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| Fujian Provincial Hospital | Recruiting | Fuzhou | 350000 | China |
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| The Second Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | 150001 | China |
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| Nanjing Drum Tower Hospital | Recruiting | Nanjing | 210008 | China |
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| Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200025 | China |
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| Fuwai Shenzhen Hospital Chinese Academy of Medical Sciences | Recruiting | Shenzhen | 51000 | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | 830054 | China |
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| Wuhan Asia General Hospital | Recruiting | Wuhan | 430000 | China |
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| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | 361001 | China |
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| Klinička Bolnica Dubrava | Recruiting | Zagreb | 10000 | Croatia |
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| Klinički Bolnički Centar Zagreb (KBC) | Recruiting | Zagreb | 10000 | Croatia |
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| Centre Hospitalier Universitaire de Grenoble - Site Nord | Recruiting | Grenoble | 38700 | France |
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| Les Hôpitaux de Chartres - Hôpital Louis Pasteur | Recruiting | Le Coudray | 28630 | France |
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| Hôpital Privé Jacques Cartier | Recruiting | Massy | 91300 | France |
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| Hôpital Européen Georges Pompidou | Recruiting | Paris | 75015 | France |
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| Clinique Pasteur | Recruiting | Toulouse | 31076 | France |
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| Universitäts Klinikum Frankfurt - Goethe-Universität | Recruiting | Frankfurt | 60590 | Germany |
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| Universitätsklinikum Heidelberg | Recruiting | Heidelberg | 69120 | Germany |
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| St. Vincenz Krakenhaus Paderborn | Recruiting | Paderborn | 33098 | Germany |
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| St. Vincenz-Krankenhaus Paderborn | Recruiting | Paderborn | 33098 | Germany |
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| Bioclinic Athens | Recruiting | Athens | 11524 | Greece |
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| IRCCS Ospedale Sacro Cuore Don Calabria | Recruiting | Negrar | Verona | 37024 | Italy |
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| Azienda Ospedaliera di Ancona | Recruiting | Ancona | 60030 | Italy |
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| St Antonius Ziekenhuis | Recruiting | Nieuwegein | 3435 CM | Netherlands |
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| Spitalul Clinic Județean de Urgență Brașov | Recruiting | Brasov | 500826 | Romania |
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| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | Seoul | 03080 | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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| Severance Hospital | Recruiting | Seoul | 120-752 | South Korea |
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| Hospital Universitario Reina Sofía | Recruiting | Córdoba | 14004 | Spain |
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| H. Univ. Virgen de la Victoria - Malaga | Recruiting | Málaga | 29010 | Spain |
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| Complejo Asistencial Universitario de Salamanca | Recruiting | Salamanca | 37007 | Spain |
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| Basildon and Thurrock University Hospitals | Not yet recruiting | Basildon | SS16 5NL | United Kingdom |
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| University Hospitals Coventry & Warwickshire | Recruiting | Coventry | CV2 2DX | United Kingdom |
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| Saint Georges University Hospitals - NHS Trust | Recruiting | London | SW17 0QT | United Kingdom |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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