PULSTA Transcatheter Pulmonary Valve Pre-Approval Study
NCT ID: NCT03983512
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
58 participants
INTERVENTIONAL
2019-10-07
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PULSTA TPV
PULSTA Transcatheter Pulmonary Valve (TPV) System
PULSTA TPV System
PULSTA transcatheter pulmonary valve replacement.
Interventions
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PULSTA TPV System
PULSTA transcatheter pulmonary valve replacement.
Eligibility Criteria
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Inclusion Criteria
* Pulmonary regurgitation moderate or severe pulmonary regurgitation or pulmonary valve stenosis with mean gradient \>35mmHg by echocardiography
* Main pulmonary artery trunk of ≥16 mm and ≤30 mm
* Patients willing to provide written informed consent and comply with follow-up evaluations.
Exclusion Criteria
* Pre-existing mechanical valve in pulmonary position or require concomitant repair of other cardiac valves
* Obstruction of the central veins to be approached for the TPV implantation
* Coronary artery compression confirmed by angiography
* A known severe allergy to Nickel
* A known hypersensitivity to any anticoagulation therapy, contrast agent or a hemorrhagic disease
* Suspected active infectious disease (e.g. endocarditis, meningitis)
* Life expectancy of less than 6 months
10 Years
ALL
No
Sponsors
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Avania
INDUSTRY
Taewoong Medical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Mario Carminati, PhD. MD.
Role: STUDY_CHAIR
Policlinico San Donato
Stanimir Georgiev, PhD. MD.
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum Munchen
Jose Luis Zunzunegui, PhD. MD.
Role: PRINCIPAL_INVESTIGATOR
Gregorio Marañon hospital
Federico Gutierrez Larraya, PhD. MD.
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Paz
Ender Odemis, PhD. MD.
Role: PRINCIPAL_INVESTIGATOR
Koc University Hospital
Ahmet Çelebi, PhD. MD.
Role: PRINCIPAL_INVESTIGATOR
Siyami Ersek Hospital
Gregor Krings, PhD. MD.
Role: PRINCIPAL_INVESTIGATOR
Utrecht University Wilhelmina
Thomas Krasemann, PhD. MD.
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Gi Beom Kim, PhD. MD.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Jae Young Choi, PhD. MD.
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Seong Ho Kim, PhD. MD.
Role: PRINCIPAL_INVESTIGATOR
Sejong General Hospital
Locations
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Deutsches Herzzentrum Munchen
München, München, Germany
Policlinico San Donato
Milan, San Donato Milanese, Italy
Utrecht University Wilhelmina
Utrecht, Utrecht, Netherlands
Erasmus Medical Center
Rotterdam, Wytemaweg, Netherlands
Seoul National University Hospital
Seoul, Haehak-ro Jongno-gu, South Korea
Sejong General Hospital
Bucheon-si, Hohyun-ro, Sosa-gu, South Korea
Severance Hospital
Seoul, Yonsei-ro, Seodaemun-gu, South Korea
Gregorio Marañon hospital
Madrid, Madrid, Spain
University Hospital La Paz
Madrid, Madrid, Spain
Koc University Hospital
Istanbul, Topkapı, Zetinburnu/İstanbul, Turkey (Türkiye)
Siyami Ersek Hospital
Istanbul, Üsküdar/İstanbul, Turkey (Türkiye)
Countries
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Other Identifiers
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TWTPV-E1001
Identifier Type: -
Identifier Source: org_study_id
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