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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02700100
Recruitment Status : Active, not recruiting
First Posted : March 7, 2016
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Xeltis

Tracking Information
First Submitted Date  ICMJE February 15, 2016
First Posted Date  ICMJE March 7, 2016
Last Update Posted Date April 8, 2021
Study Start Date  ICMJE June 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2016)
  • 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. [ Time Frame: 12 months ]
  • 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. [ Time Frame: 6 and 12 months ]
  • 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. [ Time Frame: 12 months ]
  • 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. [ Time Frame: 12 months ]
    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). [ Time Frame: Intraoperative ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Safety of the Pulmonary Valved Conduit (PV-001) in Subjects Undergoing Right Ventricular Outflow Tract Reconstruction
Official Title  ICMJE 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
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:

  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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Congenital Heart Disease
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: Pulmonary Valved Conduit (PV-001)
Bioabsorbable Pulmonary Valved Conduit (PV-001) implantation through open surgery.
Intervention: Device: Bioabsorbable Pulmonary Valved Conduit (PV-001)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 1, 2016)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient requiring RVOT reconstruction, suitable for 16 mm or 18 mm conduit.
  2. Male or Female.
  3. Age > 2 years and < 22 years.
  4. Right Ventricular to Pulmonary Artery peak gradient > 35mm Hg or moderate or severe Pulmonary Valve regurgitation (≥3+), or have both.
  5. 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.
  6. 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:

  1. Need for or presence of prosthetic valve at other position.
  2. Need for concomitant surgical procedures (outside of the heart).
  3. Patients with previously implanted pacemaker (including defibrillators), or mechanical valves.
  4. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics).
  5. Active endocarditis.
  6. Leukopenia.
  7. Acute or chronic anaemia.
  8. Thromocytopenia.
  9. Severe chest wall deformity.
  10. Right ventricular outflow tract aneurysm.
  11. Known hypersensitivity to anticoagulants and antiplatelet drugs.
  12. Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immunostimulant drugs.
  13. Need for emergency cardiac or vascular surgery or intervention.
  14. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year.
  15. Currently participating, or participated within the last 30 days, in an investigational drug or device study.
  16. 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.
  17. Pregnancy.
  18. Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years
  19. Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Malaysia,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02700100
Other Study ID Numbers  ICMJE XEL-CR-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Xeltis
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Xeltis
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thierry Carrel, MD University Hospital Inselspital, Berne
PRS Account Xeltis
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP