PULSTA Transcatheter Pulmonary Valve Pre-Approval Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Heart Diseases
- Pulmonary Valve Regurgitation
- Pulmonary Valve Stenosis
- Tetralogy of Fallot
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 10 years and 125 years
- Gender
- Both males and females
Description
The PULSTA TPV is a self-expandable valve with flared-ends to adapt to the larger native right ventricular outflow tract (RVOT) and is using a relatively low profile delivery catheter from knitted nitinol wire backbone and trileaflets made from treated porcine pericardial tissue, and a delivery syst...
The PULSTA TPV is a self-expandable valve with flared-ends to adapt to the larger native right ventricular outflow tract (RVOT) and is using a relatively low profile delivery catheter from knitted nitinol wire backbone and trileaflets made from treated porcine pericardial tissue, and a delivery system, which provides access to the right ventricular outflow tract through blood vessels. Consecutive subject data should be collected at discharge, 1, 6 months, and 1-5 years post PULSTA TPV implantation.
Tracking Information
- NCT #
- NCT03983512
- Collaborators
- Factory CRO
- Investigators
- Study Chair: Mario Carminati, PhD. MD. Policlinico San Donato Principal Investigator: Andreas Eicken, PhD. MD. Deutsches Herzzentrum Munchen Principal Investigator: Jose Luis Zunzunegui, PhD. MD. Gregorio Marañon hospital Principal Investigator: Federico Gutierrez Larraya, PhD. MD. Hospital Universitario La Paz Principal Investigator: Ender Odemis, PhD. MD. Acibadem University Hospital Principal Investigator: Ahmet Çelebi, PhD. MD. Siyami Ersek Hospital Principal Investigator: Gregor Krings, PhD. MD. Utrecht University Wilhelmina Principal Investigator: Thomas Krasemann, PhD. MD. Erasmus Medical Center Principal Investigator: Gi Beom Kim, PhD. MD. Seoul National University Hospital Principal Investigator: Jae Young Choi, PhD. MD. Severance Hospital Principal Investigator: Seong Ho Kim, PhD. MD. Sejong Hospital
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