Xeltis Pulmonary Valved Conduit Safety and Performance Study

NCT03405636 | Withdrawn DMC

• 1 other identifier: XEL-CR-02
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 4

Brief Summary

This is a multi-center prospective, single-arm, non-randomized, open label study to assess safety and performance of the Xeltis Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations.

Conditions

Heart Defects, Congenital

Outcome Measures

Primary Outcomes (1)

• Survival at 12 months follow up post implantation

  Measured by the fact that the patient is still alive at the time of the 12 month FU visit

  12 months

Secondary Outcomes (3)

• Freedom from device related death, intervention and/or reoperation at 12 months follow up

  12 months

• Mean pressure gradient across the area of conduit implantation (RV to PA) of less than 40 mm Hg at 12 months follow up

  12 months

• Pulmonary regurgitation of equal or less than moderate (≤40 %) at 12 months follow up

  12 months

Study Arms (1)

Xeltis Pulmonary Valved Conduit

EXPERIMENTAL

PV Conduit for RVOT reconstruction

Device: Xeltis Pulmonary Valved Conduit

Interventions

Xeltis Pulmonary Valved Conduit DEVICE

RVOT reconstruction

Xeltis Pulmonary Valved Conduit

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient requiring RVOT reconstruction, suitable for 16 mm or 18 mm valved conduit.
• Male or Female.
• Age \< 22 years.
• Right Ventricular to Pulmonary Artery mean gradient \> 35mm Hg or moderate or severe Pulmonary 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 clinical investigation plan required follow-up visits.

You may not qualify if:

• Need for or presence of prosthetic heart valve at other position
• Need for concomitant surgical procedures (non-cardiac)
• Patients with previously implanted pacemaker (including defibrillators) or mechanical valves
• Active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)
• Active endocarditis
• Leukopenia, according to local laboratory evaluation of white blood cell count
• Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria
• Thrombocytopenia, defined as Platelet count \< 150,000/mm3 Patients can be transfused to meet eligibility criteria
• Severe chest wall deformity, which would preclude placement of the PV conduit
• Pulmonary hypertension (right ventricular systolic pressure ≥ half of systemic systolic pressure)
• Right ventricular outflow tract aneurysm
• Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials
• Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs
• Patient has chronic inflammatory / autoimmune disease
• Need for emergency cardiac or vascular surgery or intervention

Sponsors & Collaborators

• Xeltis: lead

Study Sites (4)

Gottsegen György Hungarian Institute of Cardiology, Paediatric Cardiac Centre

Budapest, H-1096, Hungary

Location

Institute Jantung Negara, National Heart Institute

Kuala Lumpur, Malaysia

Location

University Children's Hospital of Cracow (UCH),

Krakow, 30-663, Poland

Location

Childrens Heart Centre Slovak Republic

Bratislava, Slovakia

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: January 23, 2018
• Study Start: September 1, 2020
• Primary Completion: October 1, 2021
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1); PL (1); SL (1); HU (1)