INSPIRIS RESILIA Valve in Pulmonary Position

INSPIRIS RESILIA Valve in Pulmonary Position - A Prospective Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease; Pulmonary Valve Disorder
• Intervention / Treatment: Procedure: Pulmonary valve replacement

Detailed Description

Up to 40 subjects will be invited to participate in this trial after the indication for pulmonary valve replacement has been established. At the inclusion visit, patients will be screened according to the inclusion / exclusion criteria. After written informed consent, a detailed history will be obtained, and the study related exams will be performed.

The procedure will be performed through a median sternotomy with the help of cardiopulmonary bypass in a beating or arrested heart fashion depending on the individual surgeon's discretion. Any additional or residual defects will concomitantly be addressed. Either a native or prosthetic pulmonary valve will be replaced by an Edwards Inspiris valve (Edwards Lifesciences, Unterschleissheim, Germany). If a conduit is required, the valve will be sewn into a suitable prosthesis beforehand.

Subjects will be seen regularly after pulmonary valve implantation at hospital discharge, 6-month, 1 year and 2 years after surgery. A cardiac magnetic resonance imaging will be performed at inclusion and 2 years after surgery.

Total enrollment period for the study is estimated to be two years. The trial starts with the enrollment of the first patients and ends after the last patient enrolled has completed the two-year visit or has exited the study.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Daniel Zimpfer, Prof. PD. Dr.; Phone Number: + 43 1 40400 56200; Email: daniel.zimpfer@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Daniel Zimpfer, Prof. PD. Dr.; Phone Number: + 43 1 40400 56200; Email: daniel.zimpfer@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 95 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

1. pulmonary valve disease requiring pulmonary valve replacement of their native or prosthetic valve, equal to or greater than five years of age.
2. 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.
3. The patient has completed all preoperative investigations.

Exclusion Criteria:

1. Requires emergency surgery
2. Has acute myocardial infarction (MI) within 30 days prior to screening date
3. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within six months prior to screening date
4. Has hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to screening date
5. Has active endocarditis/myocarditis or endocarditis/myocarditis within three months prior to screening date
6. Has renal insufficiency as determined by creatinine level ≥ 2.5 mg/dL within 60 days prior to screening visit or end-stage renal disease

7. Has documented:

   1. leukopenia (WBC < 3.5x 103/µL),
   2. acute anemia (Hgb<10.0 g/dL or 6 mmol/L), or
   3. thrombocytopenia (platelet count < 50x 103/µL) accompanied by history of bleeding diathesis or coagulopathy within 60 days prior screening date

9. 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Edwards Inspiris Resilia Valve	Procedure: Pulmonary valve replacement; Surgical replacement of the pulmonary valve using the Edwards Inspiris Resilia prosthesis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoints	all-cause mortality, structural valve deterioration, paravalvular leak, non-structural valve deterioration, transvalvular leak, trial valve-related mortality, endocarditis, valve thrombosis, explant and thromboembolism	2 years after implantation

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 1888/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No