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Study to Assess Safety of the Pulmonary Valved Conduit (PV-001) in Subjects Undergoing Right Ventricular Outflow Tract Reconstruction

NCT02700100 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-04-08

No results posted yet for this study

Summary

The study is a prospective, non-randomised, open label clinical study to assess the safety of the Bioabsorbable Pulmonary Valved (PV) conduit (PV-001) in subjects \> 2 years and \< 22 years of age, undergoing Right Ventricular Outflow Tract (RVOT) reconstruction. It is a first in man feasibility study which will include 10-12 patients in up to 6 sites in Europe.

The primary objective of the study is to assess the survival rate of subjects at 6 months following implantation of the Bioabsorbable Pulmonary Valved Conduit (PV-001).

Secondary objectives:

1. The survival rate of subjects at 12 months following implantation of the Bioabsorbable Pulmonary Valved Conduit (PV-001)
2. The percentage of conduit failure at 6 months and 12 months, where conduit failure includes the need for reintervention or reoperation.
3. The pressure gradient across the pulmonary valve will have an acceptable level at 12 months follow up.
4. The pulmonary regurgitation measured will not exceed a moderate grading at 12 months follow up.
5. To evaluate the usability of the Bioabsorbable Pulmonary Valved Conduit (PV-001) during the surgical procedure, using exploratory parameters

Long term safety will be assessed up to 60 months post implantation.

Conditions

  • Congenital Heart Disease

Interventions

DEVICE

Bioabsorbable Pulmonary Valved Conduit (PV-001)

The Bioabsorbable Pulmonary Valved (PV) Conduit (PV-001) is a polymer-based medical device, with a total length of 8 cm with inner diameters of 16 or 18 mm. The valve itself is formed by three leaflets, incorporated within the conduit wall. The PV conduit is used for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT) in patients with any of the following congenital heart malformations: * Tetralogy of Fallot * Truncus Arteriosus * Pulmonary Atresia * Transposition of Great Arteries with Ventricular Septal Defect (VSD) * Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes The PV conduit can also be used for replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits.

Sponsors & Collaborators

  • Xeltis

    lead INDUSTRY

Principal Investigators

  • Thierry Carrel, MD · Insel Gruppe AG, University Hospital Bern

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-06-30
Completion
2022-04-30

Countries

  • Hungary
  • Malaysia
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02700100 on ClinicalTrials.gov