Transcatheter Pulmonary Valve Implantation With SAPIEN 3 Valve

NCT05264181 | Unknown DMC FDA Device

• 1 other identifier: 2022-564
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Background Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right ventricular outflow tract dysfunction in patients with congenital heart diseases. Long-term outcomes following this procedure using the new generation SAPIEN 3 valve is little known. Purpose This study aims to report mid-term outcomes in a large cohort of patients who had TPVI using the SAPIEN 3 valve. Methods We designed a retrospective multicentre observational registry of patients undergoing TPVI with the SAPIEN 3 valve across centres in Europe, Middle-east and Canada. Patient-related, procedural, and mid-term outcomes data will be characterized.

Conditions

Pulmonary Valve; Failure; Percutaneous Pulmonary Valve Implantation; Infective Endocarditis; Congenital Heart Disease

Keywords

percutaneous pulmonary valve implantation; SAPIEN 3; transcatheter pulmonary valve replacement; infective endocarditis; Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• secondary pulmonary valve replacement

  annualized incidence of secondary valve replacement by catheterization or surgery for SAPIEN 3 valve failure

  5 years

Secondary Outcomes (2)

• Infective endocarditis

  5 years

• Thrombosis

  5 years

Interventions

Percutaneous pulmonary valve implantation DEVICE

Percutaneous pulmonary valve implantation using SAPIEN 3 valve in the context of routine care of patients with congenital heart diseases

Eligibility Criteria

• Age: 5 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion criteria were a clinical indication for PPVI in the pulmonic position, with the decision to perform the procedure taken independently. So as to represent the broadest possible spectrum of patients undergoing PPVI, no further inclusion/exclusion criteria were stipulated. PPVI is usually indicated in symptomatic patients with congenital heart diseases or those with evidence of RV or left ventricular systolic dysfunction, severe RV enlargement with an indexed RV end-diastolic volume of greater than 160 mL/m2, or an indexed RV end-systolic volume of greater than 80 mL/m2 and those with decreases in exercise capacity.

You may qualify if:

• Patient with congenital heart disease, dysfunctional right ventricle outflow tract and indications for percutaneous pulmonary valve replacement as indicated by international guidelines-
• Patient having a valve replacement using a SAPIEN 3 valve

You may not qualify if:

• Patient having a valve replacement using a SAPIEN XT valve
• Patient having a valve replacement using a Melody valve
• Patient having a valve replacement using a Harmony valve
• Patient having a valve replacement using a Venus-P valve
• Patient refusing participation to the study

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead
• Institut für Pharmakologie und Präventive Medizin: collaborator

Study Sites (1)

Hopital Marie Lannelongue

Le Plessis-Robinson, 92350, France

RECRUITING

MeSH Terms

Conditions

Endocarditis; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Alain Fraisse, MD, PhD

  Royal Brompton & Harefield NHS Foundation Trust

  STUDY DIRECTOR

Central Study Contacts

Sebastien Hascoet, MD, PhD

CONTACT

0140942429; s.hascoet@ghpsj.fr

Estibaliz Valdeolmillos, MD

CONTACT

evaldeolmillos@ghpsj.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)