Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-04-26 @ 1:58 AM
Study NCT ID:
NCT03191656
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2017-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REDUCE LAP-HF III Corvia Protocol 1701
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2017-06-12', 'studyFirstSubmitQcDate': '2017-06-16', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serious Adverse Events', 'timeFrame': '30 days', 'description': 'Device and or procedure related serious adverse cardiac events'}, {'measure': 'New York Heart Classification', 'timeFrame': '12 months', 'description': 'Improvement in NYHA Classification'}, {'measure': 'Quality of Life Improvement (KCCQ score)', 'timeFrame': '12 months', 'description': 'Improvement in KCCQ score'}, {'measure': 'Quality of Life Improvement (EQ5D)', 'timeFrame': '12 months', 'description': 'Improvement in EQ5D score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'This is a post market trial to be conducted at sites in Germany. The device has CE approval in the EU. The purpose of this observational registry is to collect post market data in consecutive patients treated with the IASD System II, to further evaluate efficacy, safety and quality of life outcomes as a new treatment for patients with heart failure in a "real world" practice setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF) with elevated left atrial pressures, who remain symptomatic despite standard Guideline Directed Medical Therapy (GDMT), in accordance with CE-mark approved labeling.', 'healthyVolunteers': False, 'eligibilityCriteria': 'This is a post market registry so no criteria requirements (only recommendations).'}, 'identificationModule': {'nctId': 'NCT03191656', 'acronym': 'REDUCELAPHFIII', 'briefTitle': 'REDUCE LAP-HF III Corvia Protocol 1701', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corvia Medical'}, 'officialTitle': 'A Post-Market Clinical Follow-up Study to Evaluate the Corvia Medical, Inc. InterAtrial Shunt Device - IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure', 'orgStudyIdInfo': {'id': '1701'}}, 'armsInterventionsModule': {'interventions': [{'name': 'IASD Implant', 'type': 'DEVICE', 'description': 'Implantation of the IASD device using trans-septal puncture and the IASD system'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bad Nauheim', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Mortiz Hass, MD', 'role': 'CONTACT'}], 'facility': 'Herzzentrum der Kerckhoff-Klinik', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'city': 'Bad Oeynhausen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Daniel Dumitrescu, MD', 'role': 'CONTACT'}], 'facility': 'Herz- und Diabeteszentrum Nordrhein-Westfalen Klinik für Kardiologie', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Bad Segeberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Leon Iden, MD', 'role': 'CONTACT'}], 'facility': 'Segeberger Kliniken GmbH', 'geoPoint': {'lat': 53.93775, 'lon': 10.30745}}, {'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sebasian Winkler, MD', 'role': 'CONTACT'}], 'facility': 'Unfallkrankenhaus Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Chemnitz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Karim Ibrahim, MD', 'role': 'CONTACT'}], 'facility': 'Klinikum Chemnitz gGmbH', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Roman Pfister, MD', 'role': 'CONTACT'}], 'facility': 'Herzzentrum der Universität zu Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Detmold', 'status': 'TERMINATED', 'country': 'Germany', 'facility': 'Klinikum Lippe GmbH', 'geoPoint': {'lat': 51.93855, 'lon': 8.87318}}, {'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Axel Linke, MD', 'role': 'CONTACT'}], 'facility': 'Herzzentrum Dresden GmbH', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ralf Westenfeld, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie u. Angiologie', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Essen', 'status': 'TERMINATED', 'country': 'Germany', 'facility': 'Elisabeth-Krankenhaus Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Giessen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Holger Nef, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Gießen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'city': 'Göttingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Gerd Hasenfuss, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Halle', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'J Tongers, MD', 'role': 'CONTACT'}], 'facility': 'Universitäts Klinikum Halle', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Heilbronn', 'status': 'TERMINATED', 'country': 'Germany', 'facility': 'Klinikum am Plattenwald Bad Friedrichshall', 'geoPoint': {'lat': 49.13995, 'lon': 9.22054}}, {'city': 'Karlsburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Basil Alkhlout, MD', 'role': 'CONTACT'}], 'facility': 'Klinikum Karlsburg', 'geoPoint': {'lat': 53.97172, 'lon': 13.61007}}, {'city': 'Kiel', 'status': 'TERMINATED', 'country': 'Germany', 'facility': 'Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie, Angiologie und internistische', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Leipzig', 'status': 'TERMINATED', 'country': 'Germany', 'facility': 'Klinikum Sankt Georg', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Lübeck', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'T. Schmidt, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Münster', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Rudin Pistulli, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Munster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Osnabrück', 'status': 'TERMINATED', 'country': 'Germany', 'facility': 'Niels-Stensen-Kliniken - Marienhospital', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'city': 'Paderborn', 'status': 'TERMINATED', 'country': 'Germany', 'facility': 'St Vincenz-Kranenhaus', 'geoPoint': {'lat': 51.71905, 'lon': 8.75439}}, {'city': 'Rotenburg (Wümme)', 'status': 'TERMINATED', 'country': 'Germany', 'facility': 'Herz-Kreislauf-Zentrum Rotenburg', 'geoPoint': {'lat': 53.11032, 'lon': 9.4036}}, {'zip': '19049', 'city': 'Schwerin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Pauline Herke', 'role': 'CONTACT'}, {'name': 'Philipp Hammer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Helios Kliniken Schwerin', 'geoPoint': {'lat': 53.62937, 'lon': 11.41316}}, {'city': 'Ülm', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Mirjam Kessler, MD', 'role': 'CONTACT'}], 'facility': 'Universitätsklinik Ulm-Keßler'}, {'city': 'Wittenberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Franz Kleber, Prof', 'role': 'CONTACT'}], 'facility': 'Evangelisches Krankenhaus Paul Gerhardt Stift - Unfallstation', 'geoPoint': {'lat': 51.8661, 'lon': 12.64973}}, {'city': 'Zwickaü', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Holger Sigusch, MD', 'role': 'CONTACT'}], 'facility': 'Heinrich Braun Klinikum'}, {'city': 'Solothurn', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Rolf Vogel, Prof', 'role': 'CONTACT'}], 'facility': 'Bürgelspital Solothurn', 'geoPoint': {'lat': 47.20791, 'lon': 7.53714}}], 'centralContacts': [{'name': 'Jan Komtebedde, DVM', 'role': 'CONTACT', 'email': 'jkomtebedde@corviamedical.com', 'phone': '978-654-6113'}, {'name': 'Felix DeLaRosa', 'role': 'CONTACT', 'email': 'fdelarosa@corviamedical.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corvia Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}