A Prospective, Observational Registry Study Designed to Collect Real-world Hemodynamic and Clinical Outcomes of the INSPIRIS RESILIA Aortic Valve

Real-world study of the INSPIRIS RESILIA Aortic Valve in patients needing valve replacement.

NCT: NCT07120048 · Status: RECRUITING · Phase: N/A · Sponsor: Edwards Lifesciences · Started: 2025-07-30 · Est. Completion: 2026-12

Plain English Summary

Real World Data Collection on the INSPIRIS RESILIA Aortic Valve is a Not Applicable clinical trial sponsored by Edwards Lifesciences studying Aortic Valve Disease. This study observes how well the INSPIRIS RESILIA aortic valve works in patients who need their aortic valve replaced. It is for adults (18+) who are having or have had their aortic valve replaced with this specific device. Participation involves having the valve replaced and then having regular check-ups and tests to monitor the valve's performance. There are no alternative treatments being tested in this study; it focuses on observing the outcomes of patients who receive the INSPIRIS RESILIA valve as part of their standard care. The trial aims to enroll 500 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older who require an aortic valve replacement with the INSPIRIS RESILIA valve. Patients must have standard pre-procedure imaging tests like echocardiography and CT scans available. Individuals with active heart infections or those undergoing emergency surgery cannot participate. Patients needing other heart valve procedures during the same surgery will also be excluded. This trial is studying Aortic Valve Disease, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The study will measure how well blood flows through the new valve and how much blood might leak backward, indicating the valve's effectiveness in restoring normal heart function. The specific primary outcome measures are: Subject's average mean gradient measurement over time (Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months); Subject's average peak gradient measurement over time (Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months); 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); 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). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This study is important because it will provide real-world data on how the INSPIRIS RESILIA aortic valve performs, helping to understand its effectiveness and safety in a broader patient population be This research targets Aortic Valve Disease, where improved treatment options are needed.

Investor Insight

This observational study by Edwards Lifesciences, a major medical device company, aims to gather data on a specific aortic valve, potentially supporting its long-term adoption and market presence in t

Is This Trial Right for Me?

Ask your doctor about the specific benefits and risks of the INSPIRIS RESILIA valve for your condition. Understand that participation means agreeing to follow-up appointments and tests to monitor the valve's performance after surgery. Your daily life will likely involve recovery from surgery, followed by regular medical check-ups as scheduled by the study. This trial is currently recruiting participants. The trial is being conducted at 11 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

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

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07120048?

NCT07120048 is a Not Applicable OBSERVATIONAL study titled "Real World Data Collection on the INSPIRIS RESILIA Aortic Valve." It is currently recruiting and is sponsored by Edwards Lifesciences. The trial targets enrollment of 500 participants.

What conditions does NCT07120048 study?

This trial investigates treatments for Aortic Valve Disease. The primary condition under study is Aortic Valve Disease.

What treatments are being tested in NCT07120048?

The interventions being studied include: Edwards INSPIRIS RESILIA Aortic Valve (DEVICE). Surgical replacement of the aortic valve with the Edwards INSPIRIS RESILIA Aortic Valve

What does Not Applicable mean for NCT07120048?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT07120048?

This trial is currently "Recruiting." It started on 2025-07-30. The estimated completion date is 2026-12.

Who is sponsoring NCT07120048?

NCT07120048 is sponsored by Edwards Lifesciences. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07120048?

The trial aims to enroll 500 participants. The trial is currently recruiting and accepting new participants.

How is NCT07120048 designed?

This is a observational study.

What are the primary outcomes being measured in NCT07120048?

The primary outcome measures are: Subject's average mean gradient measurement over time (Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months); Subject's average peak gradient measurement over time (Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months); 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); 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). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07120048 being conducted?

This trial is being conducted at 11 sites, including Heidelberg, Baden-Wurttemberg; Bad Neustadt an der Saale, Bavaria; Erlangen, Bavaria; Munich, Bavaria and 7 more sites (Germany).

Where can I find official information about NCT07120048?

The official record for NCT07120048 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07120048. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07120048 testing in simple terms?

This study observes how well the INSPIRIS RESILIA aortic valve works in patients who need their aortic valve replaced. It is for adults (18+) who are having or have had their aortic valve replaced with this specific device.

Why is this trial significant?

This study is important because it will provide real-world data on how the INSPIRIS RESILIA aortic valve performs, helping to understand its effectiveness and safety in a broader patient population be

What are the potential risks of participating in NCT07120048?

Potential risks include bleeding, infection, blood clots, and stroke, similar to any heart surgery. Specific to the valve, there's a possibility of the valve not working perfectly, leading to leakage or restricted blood flow. Some patients might experience discomfort or pain at the surgical site, or irregular heart rhythms. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07120048?

Ask your doctor about the specific benefits and risks of the INSPIRIS RESILIA valve for your condition. Understand that participation means agreeing to follow-up appointments and tests to monitor the valve's performance after surgery. Your daily life will likely involve recovery from surgery, followed by regular medical check-ups as scheduled by the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07120048 signal from an investment perspective?

This observational study by Edwards Lifesciences, a major medical device company, aims to gather data on a specific aortic valve, potentially supporting its long-term adoption and market presence in t This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves having the valve replaced and then having regular check-ups and tests to monitor the valve's performance. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.