A Real-World Evidence Observational Study of VenusP-ValveTM System in the Treatment of Patients with Native RVOT Dysfunction
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with native right ventricular outflow tract (RVOT).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 70
Healthy Volunteers: f
View:
• Patients with native RVOT (including transvalvular patch repair) are present with moderate or greater pulmonary regurgitation with/without stenosis and are clinically indicated for pulmonary valve intervention.
• The patient (or the patient's legally authorized representative) is willing to consent to participate in the study and will commit to completing all follow-up requirements.
Locations
Other Locations
France
Marie Lannelongue
RECRUITING
Le Plessis-robinson
Chu Nantes
RECRUITING
Nantes
Hopital Necker-Enfants malades
RECRUITING
Paris
CHU Bordeaux
NOT_YET_RECRUITING
Pessac
Germany
Clinic of Congenital Heart Disease
NOT_YET_RECRUITING
Berlin
Heart CenterMunich
NOT_YET_RECRUITING
Munich
Italy
S. Donato Milan
NOT_YET_RECRUITING
Milan
OPBG Rome
NOT_YET_RECRUITING
Rome
United Kingdom
Leeds General Infirmary
NOT_YET_RECRUITING
Leeds
Evelina Children's Hospital
NOT_YET_RECRUITING
London
Contact Information
Primary
Cong Ma
macong@venusmedtech.com
+86 18817939751
Backup
Ping Zhang
zhangping@venusmedtech.com
15802168031
Time Frame
Start Date: 2024-08-26
Estimated Completion Date: 2032-12
Participants
Target number of participants: 200
Related Therapeutic Areas
Sponsors
Collaborators: IQVIA MedTech BV of Antwerp, Belgium, MDCECRO LLC
Leads: Venus MedTech (HangZhou) Inc.