Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT06393920
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2024-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PulseSelect™ PFA Global Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Poland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-04-28', 'studyFirstSubmitQcDate': '2024-04-28', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy-Freedom from Atrial Fibrillation', 'timeFrame': '≥ 91 days after the index ablation procedure', 'description': 'Estimate the freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.'}, {'measure': 'Safety- Freedom from Device/Procedure Related Adverse Events', 'timeFrame': 'Within 6 months post-ablation', 'description': 'Estimate serious device and serious procedure-related adverse events for the PulseSelect™ PFA system'}]}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is ≥ 18 years of age or minimum age as required by local regulations.\n* Subject has been diagnosed with atrial fibrillation (AF)\n* Planned procedure using commercially available PulseSelect™ PFA System.\n* 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.\n\nExclusion Criteria:\n\n* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.\n* Subject with exclusion criteria required by local law."}, 'identificationModule': {'nctId': 'NCT06393920', 'briefTitle': 'PulseSelect™ PFA Global Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Ablation Solutions'}, 'officialTitle': 'PulseSelect PFA Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform', 'orgStudyIdInfo': {'id': 'PulseSelect™ PFA Registry'}}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jason Andrade, MD', 'role': 'CONTACT', 'email': 'jason.andrade@vch.ca', 'phone': '(778) 558-5813'}], 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Atul Verma, MD', 'role': 'CONTACT', 'email': 'atul.verma@mcgill.ca', 'phone': '(514) 934-1934'}], 'facility': 'McGill University Health Centre (MUHC)', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '150001', 'city': 'Harbin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shufeng Li', 'role': 'CONTACT', 'email': 'drlishufeng@163.com', 'phone': '+86 13304505989'}], 'facility': 'The Second Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '210008', 'city': 'Nanjing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Xu', 'role': 'CONTACT', 'email': '13390900868@163.com'}], 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '430000', 'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xi Su', 'role': 'CONTACT', 'email': 'yaxin_suxi@163.com'}], 'facility': 'Wuhan Asia General Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '38700', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pascal Defaye, MD', 'role': 'CONTACT', 'email': 'pdefaye@chu-grenoble.fr', 'phone': '+33 476765437'}], 'facility': 'Centre Hospitalier Universitaire de Grenoble - Site Nord', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '91300', 'city': 'Massy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jerome Lacotte, MD', 'role': 'CONTACT', 'email': 'drjlacotte@gmail.com', 'phone': '+33 160136060'}], 'facility': 'Hôpital Privé Jacques Cartier', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'zip': '31076', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Serge Boveda', 'role': 'CONTACT', 'email': 'sboveda@clinique-pasteur.com', 'phone': '+33 562211645'}], 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '60590', 'city': 'Frankfurt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Reza Wakili', 'role': 'CONTACT', 'email': 'reza.wakili@herz-frankfurt.de', 'phone': '+49 6963014803 (-86890)'}], 'facility': 'Universitäts Klinikum Frankfurt - Goethe-Universität', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Patrick Lugenbiel', 'role': 'CONTACT', 'email': 'patrick.lugenbiel@med.uni-heidelberg.de', 'phone': '+49 6221568676'}], 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '33098', 'city': 'Paderborn', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andreas Götte, MD', 'role': 'CONTACT', 'email': 'andreas.goette@vincenz.de', 'phone': '+49 5251861670'}], 'facility': 'St. Vincenz-Krankenhaus Paderborn', 'geoPoint': {'lat': 51.71905, 'lon': 8.75439}}, {'zip': '37024', 'city': 'Negrar', 'state': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giulio Molon, MD', 'role': 'CONTACT', 'email': 'giulio.molon@sacrocuore.it', 'phone': '+39 0456013111'}], 'facility': 'IRCCS Ospedale Sacro Cuore Don Calabria', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}, {'zip': '3435 CM', 'city': 'Nieuwegein', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Lucas Victor August Boersma, MD', 'role': 'CONTACT', 'email': 'l.boersma@antoniusziekenhuis.nl', 'phone': '+31 306099111'}], 'facility': 'St Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Il-Young Oh, MD', 'role': 'CONTACT', 'email': 'ilyoung.oh@snubh.org', 'phone': '+82 317877056'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '03080', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eue-Keun Choi', 'role': 'CONTACT', 'email': 'choiek417@gmail.com', 'phone': '+82 220720688'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young-Keun On, MD', 'role': 'CONTACT', 'email': 'yk.on@samsung.com', 'phone': '+82 234103420'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hui Nam Pak, MD', 'role': 'CONTACT', 'email': 'hnpak@yuhs.ac', 'phone': '+82 222288459'}], 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '14004', 'city': 'Córdoba', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose María Saint-Gerons', 'role': 'CONTACT', 'email': 'jseguras@telefonica.net', 'phone': '+34 609086967'}], 'facility': 'Hospital Universitario Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '29010', 'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alberto Cordero', 'role': 'CONTACT', 'email': 'albarrerag2@gmail.com', 'phone': '+34 952603165'}], 'facility': 'H. Univ. Virgen de la Victoria - Malaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '37007', 'city': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier J Candil, MD', 'role': 'CONTACT', 'email': 'jimenezcandil@secardiologia.es', 'phone': '+34 923291100 Ex 55356'}], 'facility': 'Complejo Asistencial Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': 'SS16 5NL', 'city': 'Basildon', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Neil Srinivasan, MD', 'role': 'CONTACT', 'email': 'neil.srinivasan2@nhs.net', 'phone': '+44 1268524900'}], 'facility': 'Basildon and Thurrock University Hospitals', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Faizel Osman, MD', 'role': 'CONTACT', 'email': 'faizel.osman@uhcw.nhs.uk', 'phone': '+44 2476965668'}], 'facility': 'University Hospitals Coventry & Warwickshire', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}], 'centralContacts': [{'name': 'Josman Suri', 'role': 'CONTACT', 'email': 'josman.suri@medtronic.com', 'phone': '7635050262'}], 'overallOfficials': [{'name': 'Khaldoun Tarakji, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medtronic CAS Chief Medical Officer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Ablation Solutions', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}