International Multicenter Outcomes of Transcatheter Pulmonary Flow Restrictors in Congenital and Acquired Heart Disease

Sponsor
Fondation Hôpital Saint-Joseph
Study ID
NCT07791069
Status
Enrolling By Invitation

Conditions

  • Congenital Heart Disease

Eligibility Criteria

Sex
ALL
Age
N/A - 3 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcatheter pulmonary flow restriction — DEVICE
    Transcatheter implantation of a microvascular plug (MVP)-based pulmonary flow restrictor (PFR) in a single or bilateral pulmonary artery (PA) branch(es).

Study Details

The international multicenter registry aims to collect real-world data on clinical outcomes and evaluate the net clinical success of transcatheter microvascular plug (MVP)-based pulmonary flow restrictors (PFRs) in patients with congenital and acquired heart disease.

Key Dates

First listed
Aug 27, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
May 30, 2029
Completion
Jan 1, 2030

Study Design

Enrollment
150 participants (estimated)

Primary Outcome Measure

Net clinical success [ Time Frame: From date of device implant until the date of surgical device removal, assessed up to 24 months ]

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