RecruitingNot Applicable

Observational Study of Venus P-Valve

France, Germany200 participantsStarted 2024-08-26

Plain-language 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).

Who can participate

Age range12 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Non-hierarchical composite endpoint

Timeframe: at six months

Trial details

NCT IDNCT05835349

SponsorVenus MedTech (HangZhou) Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-08

Contact for this trial

Cong Ma

+86 18817939751 macong@venusmedtech.com

View on ClinicalTrials.gov More Right Ventricular Outflow Tract Dysfunction trials