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

Primary Purpose

Congenital Heart Disease

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Bioabsorbable Pulmonary Valved Conduit (PV-001)

About this trial

This is an interventional treatment trial for Congenital Heart Disease

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Gottsegen György Hungarian Institute of Cardiology, Paediatric Cardiac Centre
Institute Jantung Negara, National Heart Institute
University Children's Hospital of Cracow (UCH),

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pulmonary Valved Conduit (PV-001)

Arm Description

Bioabsorbable Pulmonary Valved Conduit (PV-001) implantation through open surgery.

Outcomes

Primary Outcome Measures

The survival rate of participants at 6 months following implantation of the Bioabsorbable Pulmonary Valved Conduit (PV-001),, measured by the fact that the patient is still alive at the time of the 6 month FU visit

Secondary Outcome Measures

The survival rate of participants at 12 months following implantation of the Bioabsorbable Pulmonary Valved Conduit (PV-001), measured by the fact that the patient is still alive at the time of the 12 month FU visit.

The rate of reoperation or reintervention due to PV conduit failure at 6 months and 12 months follow up , measured by the fact that the patient did not have a reoperation or reintervention during the follow up time.

The rate of patients with a mean pressure gradient across the area of PV conduit implantation (RV to PA) of less than 40 mm Hg at 12 months follow up, measured with echocardiography at 12 months follow up.

The rate of patients with pulmonary regurgitation of equal or less than moderate at 12 months follow up, measured with echocardiography at 12 months follow up.

The degree of pulmonary regurgitation (the percentage of blood that regurgitates back through the pulmonary valve due to valve insufficiency) is defined as: mild if regurgitant fraction is <20% moderate if regurgitant fraction is 20%-40%; severe if regurgitant fraction is >40%.

Overall satisfaction of the implantability of the Bioabsorbable Pulmonary Valved Conduit (PV-001), measured with a questionnaire given to the implanting surgeon at the time of implantation of the PV conduit (PV-001).

Full Information

NCT ID

NCT02700100

First Posted

February 15, 2016

Last Updated

April 6, 2021

Sponsor

Xeltis

1. Study Identification

Unique Protocol Identification Number

NCT02700100

Brief Title

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

Official Title

Prospective, Non-randomised, Open Label Clinical Study to Assess the Safety of the Bioabsorbable Pulmonary Valved Conduit (PV-001) in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xeltis

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Heart Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pulmonary Valved Conduit (PV-001)

Arm Type

Experimental

Arm Description

Bioabsorbable Pulmonary Valved Conduit (PV-001) implantation through open surgery.

Intervention Type

Device

Intervention Name(s)

Bioabsorbable Pulmonary Valved Conduit (PV-001)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Time Frame

12 months

Title

Time Frame

6 and 12 months

Title

Time Frame

12 months

Title

The rate of patients with pulmonary regurgitation of equal or less than moderate at 12 months follow up, measured with echocardiography at 12 months follow up.

Description

Time Frame

12 months

Title

Time Frame

Intraoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thierry Carrel, MD

Organizational Affiliation

Insel Gruppe AG, University Hospital Bern

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gottsegen György Hungarian Institute of Cardiology, Paediatric Cardiac Centre

City

Budapest

ZIP/Postal Code

H-1096

Country

Hungary

Facility Name

Institute Jantung Negara, National Heart Institute

City

Kuala Lumpur

Country

Malaysia

Facility Name

University Children's Hospital of Cracow (UCH),

City

Krakow

ZIP/Postal Code

30-663

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

33748192

Citation

Morales DL, Herrington C, Bacha EA, Morell VO, Prodan Z, Mroczek T, Sivalingam S, Cox M, Bennink G, Asch FM. A Novel Restorative Pulmonary Valve Conduit: Early Outcomes of Two Clinical Trials. Front Cardiovasc Med. 2021 Mar 4;7:583360. doi: 10.3389/fcvm.2020.583360. eCollection 2020.

Results Reference

derived

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

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