Real World Data Collection on the INSPIRIS RESILIA Aortic Valve

Recruiting

• Conditions: Aortic Valve Disease

• Registration Number: NCT07120048
• Lead Sponsor: Edwards Lifesciences

Brief Summary

Collect real-world data on hemodynamic and clinical outcomes of the INSPIRIS RESILIA Aortic Valve, Model 11500A, in subjects requiring replacement of their native or prosthetic aortic valve as the only heart valve procedure during the index procedure, with or without other concomitant procedures.

Detailed Description

Subjects in the INDICATE registry study will be enrolled at up to 20 sites in Germany. Up to 500 subjects will be implanted with the INSPIRIS RESILIA Aortic Valve in this registry.

Study Timeline

• Study Start: 2025-07-30
• Study First Submitted: 2025-07-31
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Patients requiring an aortic valve replacement using the INSPIRIS RESILIA aortic valve according to its intended purpose
2. Patients with standard-of-care pre-procedure imaging evaluation (echocardiography and CT) data available
3. Age ≥ 18 years
4. Provision of written informed consent

Exclusion Criteria

1. Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery
2. Emergency procedure
3. Patients requiring a non-aortic heart valve procedure during the index procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subject's average mean gradient measurement over time	Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months	Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Subject's average peak gradient measurement over time	Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months	Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
Amount of aortic transvalvular regurgitation in subjects over time	Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months	Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed by four categories, which are "no/trace leak", "a mild leak", "a moderate leak", and "a severe leak". A severe leak indicates a worsening outcome.
Amount of aortic paravalvular regurgitation in subjects over time	Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months	Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.; Paravalvular leak is evaluated by echocardiography over time. It is assessed by four categories, which are "no/trace leak", "a mild leak", "a moderate leak", and "a severe leak". A severe leak indicates a worsening outcome.

Secondary Outcome Measures

Name	Time	Method
Subject's New York Heart Association (NYHA) functional classification at 3 months as compared to baseline.	Baseline and 3 months	The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.; Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).; Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).; Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.; Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

Trial Locations

Locations (1)

TUM Klinikum Deutsches Herzzentrum; 🇩🇪 Munich, Germany