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Xeltis Pulmonary Valved Conduit Safety and Performance Study

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ClinicalTrials.gov Identifier: NCT03405636
Recruitment Status : Not yet recruiting
First Posted : January 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Xeltis

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.

Condition or disease Intervention/treatment Phase
Heart Defects, Congenital Device: Xeltis Pulmonary Valved Conduit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Non-randomized, Open Label Clinical Study to Assess the Safety and Performance of the Xeltis Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Xeltis Pulmonary Valved Conduit
PV Conduit for RVOT reconstruction
Device: Xeltis Pulmonary Valved Conduit
RVOT reconstruction




Primary Outcome Measures :
  1. Survival at 12 months follow up post implantation [ Time Frame: 12 months ]
    Measured by the fact that the patient is still alive at the time of the 12 month FU visit


Secondary Outcome Measures :
  1. Freedom from device related death, intervention and/or reoperation at 12 months follow up [ Time Frame: 12 months ]
    Measured by the fact that the patient did not die, did not have a reoperation or reintervention during the first 12 months

  2. Mean pressure gradient across the area of conduit implantation (RV to PA) of less than 40 mm Hg at 12 months follow up [ Time Frame: 12 months ]
  3. Pulmonary regurgitation of equal or less than moderate (≤40 %) at 12 months follow up [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient requiring RVOT reconstruction, suitable for 16 mm or 18 mm valved conduit.
  2. Male or Female.
  3. Age < 22 years.
  4. Right Ventricular to Pulmonary Artery mean gradient > 35mm Hg or moderate or severe Pulmonary 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 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 bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)
  5. Active endocarditis
  6. Leukopenia, according to local laboratory evaluation of white blood cell count
  7. Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria
  8. Thrombocytopenia, defined as Platelet count < 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 (right ventricular systolic pressure ≥ 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. Patient 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. Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years
  20. Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405636


Contacts
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Contact: Carin Nilsson 8668188461 carin.nilsson@xeltis.com
Contact: Helmine Verhoeven 8668188461 helmine.verhoeven@xeltis.com

Locations
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Hungary
Gottsegen György Hungarian Institute of Cardiology, Paediatric Cardiac Centre
Budapest, Hungary, H-1096
Malaysia
Institute Jantung Negara, National Heart Institute
Kuala Lumpur, Malaysia
Poland
University Children's Hospital of Cracow (UCH),
Krakow, Poland, 30-663
Slovakia
Childrens Heart Centre Slovak Republic
Bratislava, Slovakia
Sponsors and Collaborators
Xeltis

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Responsible Party: Xeltis
ClinicalTrials.gov Identifier: NCT03405636     History of Changes
Other Study ID Numbers: XEL-CR-02
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases