Observational Study of Venus P-Valve

Venus MedTech (HangZhou) Inc.200 enrolled

Overview

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).

All subjects will be followed up through five years for the observed outcome measures, which will be analyzed and reported to regulatory authorities as required. Post-procedure, a clinical visit will be scheduled at discharge, thirty days, six months, one year, and annually thereafter to five years.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Right Ventricular Outflow Tract Dysfunction

Interventions

transcatheter pulmonary valve implantation (TPVI)DEVICE

A stent-mounted valve is introduced over a guidewire and positioned in the RVOT, followed by balloon inflation to deploy the valve.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. 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. 2. 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. Exclusion Criteria: 1\. Patients with any condition contraindicated by the IFU or inability to comply with the Venus P-ValveTM System Instructions for Use or the study protocol.

Locations (10)

CHU Bordeaux

Pessac, Nouvelle-Aquitaine, France

NOT_YET_RECRUITING

Chu Nantes

Nantes, Pays de la Loire Region, France

RECRUITING

Marie Lannelongue

Outcomes

Primary Outcomes

Non-hierarchical composite endpoint

* Freedom from VenusP-ValveTM (catheter or surgical) reintervention * Acceptable hemodynamic function, defined as: 1. Mild or less regurgitation measured by echocardiography; AND 2. Mean RVOT gradient as measured by echocardiography ≤35mmHg.

Time frame: at six months

Secondary Outcomes

Procedural Success

Procedure success at 30 days, defined as: * Freedom from procedure/device-related mortality * Freedom from Venus P-ValveTM (catheter or surgical) reintervention concerning index procedure or device * Acceptable hemodynamic function * Original intended valve in situ

Time frame: at 30 days

Occurrence of Events

Occurrence of the following events through 5 years of follow-up: * All-cause mortality and procedure/device-related mortality * Venus P-ValveTM (catheter or surgical) reintervention * Venus P-ValveTM dysfunction * Serious procedure/device-related adverse events

Time frame: through five years

Functional status

New York Heart Association (NYHA) classification out to 5 years

Time frame: through five years

Health-state utility score

Health-state utility score as measured by the EQ-5D at pre-implant, 30 days, 6 months, 1 year and annually thereafter through 5 years.

Time frame: through five years

Central Contacts

Cong Ma

CONTACT

+86 18817939751 macong@venusmedtech.com

Ping Zhang

CONTACT

15802168031 zhangping@venusmedtech.com

Data from ClinicalTrials.gov

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