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

Xeltis

Status

Unknown

Conditions

Congenital Heart Disease

Treatments

Device: Bioabsorbable Pulmonary Valved Conduit (PV-001)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02700100

XEL-CR-01

Details and patient eligibility

About

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:

The survival rate of subjects at 12 months following implantation of the Bioabsorbable Pulmonary Valved Conduit (PV-001)
The percentage of conduit failure at 6 months and 12 months, where conduit failure includes the need for reintervention or reoperation.
The pressure gradient across the pulmonary valve will have an acceptable level at 12 months follow up.
The pulmonary regurgitation measured will not exceed a moderate grading at 12 months follow up.
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.

Enrollment

12 patients

Sex

All

Ages

2 to 21 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient requiring RVOT reconstruction, suitable for 16 mm or 18 mm conduit.
Male or Female.
Age > 2 years and < 22 years.
Right Ventricular to Pulmonary Artery peak gradient > 35mm Hg or moderate or severe Pulmonary Valve regurgitation (≥3+), or have both.
The patient, and the patient's parent / legal representative where appropriate, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent by signing the approved informed consent form.
The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with protocol-required follow-up visits.

Exclusion criteria

Need for or presence of prosthetic valve at other position.
Need for concomitant surgical procedures (outside of the heart).
Patients with previously implanted pacemaker (including defibrillators), or mechanical valves.
Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics).
Active endocarditis.
Leukopenia.
Acute or chronic anaemia.
Thromocytopenia.
Severe chest wall deformity.
Right ventricular outflow tract aneurysm.
Known hypersensitivity to anticoagulants and antiplatelet drugs.
Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immunostimulant drugs.
Need for emergency cardiac or vascular surgery or intervention.
Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year.
Currently participating, or participated within the last 30 days, in an investigational drug or device study.
Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months.
Pregnancy.
Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years
Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.