Clinical trial NCT03022708: Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study
Official title: Prospective, Non-randomized, Pivotal Study to Assess the Safety and Efficacy of the Bioabsorbable Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Heart Defect, Congenital
Lead sponsor: Xeltis
Sponsor class: INDUSTRY
First posted: 2017-01-16
Enrollment: 56
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring right ventricular outflow tract correction or reconstruction due to congenital heart malformations.


Eligibility criteria: Inclusion Criteria:

1. Patient requiring RVOT reconstruction, suitable for 16 mm,18 mm, 20 mm and 22 mm valved 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 regurgitation (≥3+), or have both (except for the patients undergoing a Ross procedure)
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 clinical investigation plan required follow-up visits.

Exclusion Criteria:

1. Need for or presence of prosthetic heart valve at other position.
2. Need for concomitant surgical procedures (non-cardiac).
3. Patients with previously implanted pacemaker (including defibrillators), or mechanical valves.
4. Active infection or requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics) or viral infection.
5. Active endocarditis.
6. Leukopenia, defined as White Blood cell Count \< than:

   * 2-12 years: 5.0 ×103 /μL
   * 12 years - Adult:
   * Male: 4.5×103 /μL
   * Female: 4.5 ×103 /μL
7. Acute or chronic anemia, defined as Hemoglobin \< than:

   * 2-12 years 11.5 g /dl
   * 12-18:
   * Male: 13 g /dl
   * Female 12 g /dl
   * Adult:
   * Male: 13.5 g /dl
   * Female: 12 g /dl Patients can be transfused to meet eligibility criteria
8. Thrombocytopenia, defined as Platelet count \< than:

   * 150,000/mm3 Patients can be transfused to meet eligibility criteria
9. Severe chest wall deformity, which would preclude placement of the PV conduit.
10. Pulmonary hypertension (≥ half of systemic systolic pressure)
11. Right ventricular outflow tract aneurysm.
12. Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials. .
13. Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs.
14. Subject has chronic inflammatory / autoimmune disease.
15. Need for emergency cardiac or vascular surgery or intervention.
16. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year.
17. Currently participating, or participated within the last 30 days, in an investigational drug or device study.
18. 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.
19. Pregnancy.
20. Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years
21. Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance.

Primary outcomes:
measure: Composite rate of events of device related death, re-operation or re-intervention at 12 months follow-up.
timeFrame: 12 months
Secondary outcomes:
measure: Overall rate of device related death due to device failure at 6 months follow up post implantation.
timeFrame: 6 months
measure: Overall rate of mortality at 60 months follow up post implantation.
timeFrame: 60 months
measure: Overall rate of subjects who require reoperation or re-intervention due to device failure 12 months.
timeFrame: 12 months
measure: Overall rate of subjects with a mean pressure gradient across the area of conduit implantation of less than 40 mm Hg at 6 and 12 months follow up.
timeFrame: 6 and 12 months
measure: Overall rate of subjects with pulmonary regurgitation of equal or less than moderate at 6 and 12 months follow up.
timeFrame: 6 and 12 months
Other outcomes:
measure: Measurement of growth of conduit in pediatric population measured at 6, 36, 48 and 60 months. A competent valve with increased valve diameter in age groups < 18 years in correlation with the increased body surface area.
timeFrame: Up to 60 months
measure: Overall satisfaction of the implanting surgeon of the implantation procedure of the Bio-absorbable pulmonary valve conduit
timeFrame: Day 0 - Implant
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Hollywood
country: United States
facility: Joe DiMaggio Children's Hospital
state: Florida
city: New York
country: United States
facility: New York Presbyterian Hospital - Columbia University (Xplore1)
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC (Xplore1)
state: Pennsylvania
city: Dallas
country: United States
facility: UTSW- Dallas Children's Hospital
state: Texas
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment "National cardiology hospital" EAD, Department of Congenital Heart Defects Surgery
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara Sdn Bhd
city: Kraków
country: Poland
facility: University Children's Hospital of Cracow
Study officials:
affiliation: Xeltis Inc
name: Eliane Schutte
role: STUDY_DIRECTOR
References:
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.