Clinical trial NCT05835349: Observational Study of Venus P-Valve
Official title: A Real-World Evidence Observational Study of VenusP-ValveTM System in the Treatment of Patients with Native RVOT Dysfunction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Right Ventricular Outflow Tract Dysfunction
Lead sponsor: Venus MedTech (HangZhou) Inc.
Sponsor class: INDUSTRY
Collaborators: name: IQVIA MedTech BV of Antwerp, Belgium
name: MDCECRO LLC
First posted: 2023-04-28
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Baseline enrolment criteria

* 12 years old up to 70 years old
* Weight ≥ 30kg
* With evidence of moderate or severe (≥3+) pulmonary regurgitation by Transthoracic Echocardiography (TTE)
* With \>30% pulmonary regurgitation fraction as defined by cardiac Magnetic Resonance Imaging (MRI)
* The subject is symptomatic from his/her pulmonary regurgitation or meets MRI criteria for intervention Right Ventricular Ejection Fraction (RVEF) \< 45%, Pulmonary Regurgitant Fraction (PRRF) \>30% and increased Right Ventricular End Diastolic Volume (RVEDV) Index (RVEDVI) \>150mL/m²

Brief 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Non-hierarchical composite endpoint
timeFrame: at six months
Secondary outcomes:
measure: Procedural Success
timeFrame: at 30 days
measure: Occurrence of Events
timeFrame: through five years
measure: Functional status
timeFrame: through five years
measure: Health-state utility score
timeFrame: through five years
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU Bordeaux
state: Nouvelle-Aquitaine
city: Nantes
country: France
facility: Chu Nantes
state: Pays de la Loire
city: Le Plessis-Robinson
country: France
facility: Marie Lannelongue
state: Île-de-France
city: Paris
country: France
facility: Hopital Necker-Enfants malades
state: Île-de-France
city: Munich
country: Germany
facility: Heart CenterMunich
state: Bavaria
city: Berlin
country: Germany
facility: Clinic of Congenital Heart Disease
city: Roma
country: Italy
facility: OPBG Rome
state: Lazio
city: Milan
country: Italy
facility: S. Donato Milan
state: Lombardy
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
state: England
city: London
country: United Kingdom
facility: Evelina Children's Hospital
state: England
Study officials:
affiliation: Evelina Children's Hospital
name: Shakeel A. Qureshi, MD
role: PRINCIPAL_INVESTIGATOR
References: