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Congenital Heart DiseaseNCT02700100

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

A study testing Bioabsorbable Pulmonary Valved Conduit (PV-001) in people with Congenital Heart Disease, run by Xeltis at 3 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 21 years
Conditions the study is for
Congenital Heart Disease
What is being tested?
Bioabsorbable Pulmonary Valved Conduit (PV-001)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
3 sitesin 3 countries
Study dates
Jun 2016to Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Hungary1 site

  • Gottsegen György Hungarian Institute of Cardiology, Paediatric Cardiac Centre

    Budapest, H-1096

Other trials in Hungary

Malaysia1 site

  • Institute Jantung Negara, National Heart Institute

    Kuala Lumpur

Other trials in Malaysia

Poland1 site

  • University Children's Hospital of Cracow (UCH),

    Krakow, 30-663

Other trials in Poland

About this study

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

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).

Read more

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.

Being tested
Bioabsorbable Pulmonary Valved Conduit (PV-001)
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bioabsorbable Pulmonary Valved Conduit (PV-001)Device

    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.

Study groups in NCT02700100
Study groupRoleWhat they receive
Pulmonary Valved Conduit (PV-001)ExperimentalBioabsorbable Pulmonary Valved Conduit (PV-001) implantation through open surgery.
Receives: Device: Bioabsorbable Pulmonary Valved Conduit (PV-001)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

Secondary outcomes (5)

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 6 and 12 months

  3. 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.

    Measured: 12 months

  4. 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%.

    Measured: 12 months

  5. 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).

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJun 2017
  4. Study completionApr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02700100
Sponsor's protocol ID
XEL-CR-01
Status last verified
Apr 2021
First submitted
15 Feb 2016
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33748192

Questions about this trial

What is this clinical trial studying?

A study testing Bioabsorbable Pulmonary Valved Conduit (PV-001) in people with Congenital Heart Disease, run by Xeltis at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Hungary, Malaysia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02700100, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.

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