Actively Recruiting
Observational Study of Venus P-Valve
Led by Venus MedTech (HangZhou) Inc. · Updated on 2025-01-24
200
Participants Needed
10
Research Sites
431 weeks
Total Duration
On this page
Sponsors
V
Venus MedTech (HangZhou) Inc.
Lead Sponsor
I
IQVIA MedTech BV of Antwerp, Belgium
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Observational Study of Venus P-Valve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with native RVOT (including transvalvular patch repair) who have moderate or greater pulmonary regurgitation with or without stenosis and are clinically indicated for pulmonary valve intervention.
- Patient or legally authorized representative willing to consent and able to complete all follow-up requirements.
You will not qualify if you...
- Patients with any condition that contraindicates use of the Venus P-ValveTM System or prevents compliance with its Instructions for Use or the study protocol.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
CHU Bordeaux
Pessac, New Aquitaine, France, 33600
Not Yet Recruiting
2
Chu Nantes
Nantes, Pays de la Loire Region, France, 44093
Actively Recruiting
3
Marie Lannelongue
Le Plessis-Robinson, Île-de-France Region, France, 92350
Actively Recruiting
4
Hopital Necker-Enfants malades
Paris, Île-de-France Region, France, 75015
Actively Recruiting
5
Heart CenterMunich
Munich, Bavaria, Germany, 81377
Not Yet Recruiting
6
Clinic of Congenital Heart Disease
Berlin, State of Berlin, Germany, 13353
Not Yet Recruiting
7
OPBG Rome
Rome, Lazio, Italy, 165
Not Yet Recruiting
8
S. Donato Milan
Milan, Lombardy, Italy, 20097
Not Yet Recruiting
9
Leeds General Infirmary
Leeds, England, United Kingdom, LS1 3EX
Not Yet Recruiting
10
Evelina Children's Hospital
London, England, United Kingdom, SE1 7EH
Not Yet Recruiting
Research Team
C
Cong Ma
CONTACT
P
Ping Zhang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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