INSPIRIS RESILIA Valve in Pulmonary Position

NCT05583656 | Unknown

• 1 other identifier: 1888/2018
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this trial we intend to evaluate the safety and effectiveness of the INSPIRIS valve prothesis in the pulmonary position in patients of five years or older, with congenital or acquired pulmonary valve disease, requiring replacement of their native or prosthetic pulmonary valve.

Conditions

Pulmonary Valve Disorder; Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Freedom from death and reoperation

  The primary safety endpoint for the trial is freedom from device or procedure related death and/or reoperation at 2 years after implantation.

  2 years after implantation

Secondary Outcomes (1)

• Safety endpoints

  2 years after implantation

Study Arms (1)

Edwards Inspiris Resilia Valve

Procedure: Pulmonary valve replacement

Interventions

Pulmonary valve replacement PROCEDURE

Surgical replacement of the pulmonary valve using the Edwards Inspiris Resilia prosthesis.

Edwards Inspiris Resilia Valve

Eligibility Criteria

• Age: 5 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients with pulmonary valve disease requiring pulmonary valve replacement of their native or prosthetic valve, equal to or greater than five years of age.

You may qualify if:

• pulmonary valve disease requiring pulmonary valve replacement of their native or prosthetic valve, equal to or greater than five years of age.
• Patients and/or patient´s legal representatives must provide written informed consent as approved and required by the respective institutional review board and agree to its provisions.
• The patient has completed all preoperative investigations.

You may not qualify if:

• Requires emergency surgery
• Has acute myocardial infarction (MI) within 30 days prior to screening date
• Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within six months prior to screening date
• Has hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to screening date
• Has active endocarditis/myocarditis or endocarditis/myocarditis within three months prior to screening date
• Has renal insufficiency as determined by creatinine level ≥ 2.5 mg/dL within 60 days prior to screening visit or end-stage renal disease
• Has documented:
• leukopenia (WBC \< 3.5x 103/µL),
• acute anemia (Hgb\<10.0 g/dL or 6 mmol/L), or
• thrombocytopenia (platelet count \< 50x 103/µL) accompanied by history of bleeding diathesis or coagulopathy within 60 days prior screening date
• \. Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism 10. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation 11. RVOT aneurysm unless treated during pulmonary valve replacement surgery 12. Has prior organ transplant or is currently an organ transplant candidate 13. Was previously implanted with study trial device 14. Previously implanted with an aortic, mitral, or tricuspid bioprosthetic valve or mechanical valve 16. Has presence of non-cardiac disease limiting life expectancy to less than 12 months 17. Is currently or has recently participated (within six weeks) in another investigational drug or device trial 18. Positive urine or serum pregnancy test in female subjects of child-bearing potential and/or nursing mothers 20. Currently incarcerated or unable to give voluntary informed consent 21. Documented history of substance (drug or alcohol) abuse within the last five years prior to screening date

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Daniel Zimpfer, Prof. PD. Dr.

CONTACT

+ 43 1 40400 56200; daniel.zimpfer@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 18, 2022
• Study Start: August 12, 2019
• Primary Completion: August 1, 2023
• Study Completion: February 1, 2024
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)