Actively Recruiting
Observational Study of Venus P-Valve System for Treating Right Ventricular Outflow Tract Dysfunction with Pulmonary Regurgitation or Stenosis
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
Researchers are studying the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction who have moderate or greater pulmonary regurgitation, with or without pulmonary stenosis. This observational study collects both retrospective and prospective real-world data from multiple centers to better understand the device's use in clinical practice. The study aims to gather evidence on patient outcomes over an extended period to support regulatory reporting. The main intervention involves transcatheter pulmonary valve implantation (TPVI), where a stent-mounted valve is guided into position in the RVOT and deployed by inflating a balloon. This procedure is designed to treat the valve dysfunction without open-heart surgery. The study does not randomize participants but follows them after this intervention to monitor results. Participants will be followed for five years after the procedure, with clinical visits scheduled at discharge, 30 days, six months, one year, and annually thereafter. Researchers will assess a composite outcome measure at six months and continue monitoring safety and effectiveness throughout the follow-up. The study involves regular clinical evaluations to track the valve performance and patient health over time.
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
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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
P
Ping Zhang
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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