Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study

Heart Defect, Congenital Clinical Trial

— Xplore2  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03022708
• Other study ID #: XEL-CR-03
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 8, 2017
• Est. completion date: December 2026

Study information

• Verified date: January 2023
• Source: Xeltis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 56
• Est. completion date: December 2026
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defect, Congenital
• Heart Defects, Congenital

Intervention

Device:
• Xeltis Bioabsorbable Pulmonary Valved Conduit
Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit

Locations

Country	Name	City	State
Bulgaria	Multiprofile Hospital for Active Treatment "National cardiology hospital" EAD, Department of Congenital Heart Defects Surgery	Sofia
Malaysia	Institut Jantung Negara Sdn Bhd	Kuala Lumpur
Poland	University Children's Hospital of Cracow	Kraków
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	UTSW- Dallas Children's Hospital	Dallas	Texas
United States	Joe DiMaggio Children's Hospital	Hollywood	Florida
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	New York Presbyterian Hospital - Columbia University (Xplore1)	New York	New York
United States	Children's Hospital of Pittsburgh of UPMC (Xplore1)	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Xeltis

Countries where clinical trial is conducted

United States,  Bulgaria,  Malaysia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Measured with echocardiography at 6, 36, 48 and 60 months follow up.	Up to 60 months
Other	Overall satisfaction of the implanting surgeon of the implantation procedure of the Bio-absorbable pulmonary valve conduit	Measured with a questionnaire given to the implanting surgeon at the time of implantation of the pulmonary valve conduit.	Day 0 - Implant
Primary	Composite rate of events of device related death, re-operation or re-intervention at 12 months follow-up.	Measured once all 12 month follow up visits have been completed	12 months
Secondary	Overall rate of device related death due to device failure at 6 months follow up post implantation.	Measured once all 6 month follow up visits have been completed	6 months
Secondary	Overall rate of mortality at 60 months follow up post implantation.	Measured once all 60 months follow up visits have been completed	60 months
Secondary	Overall rate of subjects who require reoperation or re-intervention due to device failure 12 months.	Measured once all 12 month follow upvisits have been completed .	12 months
Secondary	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.	Measured by echography at 6 and 12 months follow up.	6 and 12 months
Secondary	Overall rate of subjects with pulmonary regurgitation of equal or less than moderate at 6 and 12 months follow up.	Measured by echography at 6 and 12 months follow up.	6 and 12 months