SAPIEN Ultra RESILIA Durability EU Registry - The RESOUND-EU Registry
Long-term study of a new heart valve for aortic stenosis
Plain English Summary
Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve is a Not Applicable clinical trial sponsored by Institut für Pharmakologie und Präventive Medizin studying Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis, Aortic Insufficiency, Degenerative Valve Disease. This study will track how well a new type of artificial heart valve (SAPIEN 3 Ultra RESILIA) works in patients who have severe aortic stenosis. It is for adult patients (18+) who need a new aortic valve and will receive the SAPIEN 3 Ultra RESILIA valve through a minimally invasive procedure. Participation involves attending regular follow-up appointments for up to 10 years to monitor the valve's performance and your health. Alternatives include traditional open-heart surgery for valve replacement or other types of transcatheter valves. The trial aims to enroll 500 participants.
Official Summary
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older. Patients with severe aortic stenosis who are undergoing a specific minimally invasive valve replacement procedure (transfemoral TAVI) using the SAPIEN 3 Ultra RESILIA valve. Patients must be willing to commit to follow-up visits for up to 10 years. Individuals with emergency conditions, pregnant women, or those unable to provide informed consent cannot participate. This trial is studying Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis, Aortic Insufficiency, Degenerative Valve Disease, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure how safe the valve is in the short term and how successfully it functions, meaning how well it works and whether it fails or deteriorates over many years. The specific primary outcome measures are: Early Safety (1-3 months); Device Success (1-3 months); Bioprosthetic Valve Failure (3-5 years); Bioprosthetic Valve Failure (9-10 years); Structural Valve Deterioration (9-10 years). 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 trial matters because it will provide long-term data on the durability and performance of a new heart valve, potentially offering a more reliable option for patients with aortic stenosis. This research targets Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis, Aortic Insufficiency, Degenerative Valve Disease, where improved treatment options are needed.
Investor Insight
This registry focuses on a specific, advanced heart valve, indicating a market for innovative cardiovascular devices and a commitment to long-term patient outcomes, suggesting potential for future mar
Is This Trial Right for Me?
Ask your doctor about the specific risks and benefits of the SAPIEN 3 Ultra RESILIA valve compared to other treatment options. Understand the commitment required for 10 years of follow-up appointments and what these visits will entail. Discuss how the valve replacement procedure will be performed and what to expect immediately after. The trial is being conducted at 1 site. 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
- Study Type: OBSERVATIONAL
- Enrollment: 500 participants
Interventions
- PROCEDURE: Transcatheter aortic valve (S3UR) replacement (TAVR) — Elective transfemoral TAVi procedure with S3UR valve.
Primary Outcomes
- Early Safety (1-3 months)
- Device Success (1-3 months)
- Bioprosthetic Valve Failure (3-5 years)
- Bioprosthetic Valve Failure (9-10 years)
- Structural Valve Deterioration (9-10 years)
Secondary Outcomes
- Hemodynamic Valve Performance (All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year))
- Bioprosthetic Valve Failure (All follow-ups (1-3month, 1year, 3-5 year, 6-8year 9-10 year))
- Bioprosthetic Valve Dysfunction (All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year))
- Patient reported outcomes (1-3month, 1+3year Follow Up compared to BL)
- Cumulated incidence rate BVD or BVF (Up to 10 years)
Full Eligibility Criteria
Inclusion criteria: * Adult patients (≥18 years) * Patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve * Patient is willing to attend the follow-up visits up to 10 years at the center Exclusion criteria: * Lack of written informed consent * Emergency procedure * Pregnancy at time of TAVI Critieria for long-term observation (1y-10y): * Technical success at exit from procedure room (VARC-3): * Freedom from mortality * Successful access, delivery of the device, and retrieval of the delivery system * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device (excluding permanent pacemaker or PTA and stenting without major bleeding) or to a major vascular or access related, or cardiac structural complication * Absence of the following severe procedural and in-hospital complications (VARC-3 definitions): * All stroke * Bleeding type 3-4 * Myocardial infarction * Need for a second valve * Valve embolization * Coronary obstruction * Annular rupture
Trial Locations
- Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, North Rhine-Westphalia, Germany
Frequently Asked Questions
What is clinical trial NCT06953206?
NCT06953206 is a Not Applicable OBSERVATIONAL study titled "Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve." It is currently not yet recruiting and is sponsored by Institut für Pharmakologie und Präventive Medizin. The trial targets enrollment of 500 participants.
What conditions does NCT06953206 study?
This trial investigates treatments for Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis, Aortic Insufficiency, Degenerative Valve Disease. The primary condition under study is Transcatheter Aortic Valve Replacement (TAVR).
What treatments are being tested in NCT06953206?
The interventions being studied include: Transcatheter aortic valve (S3UR) replacement (TAVR) (PROCEDURE). Elective transfemoral TAVi procedure with S3UR valve.
What does Not Applicable mean for NCT06953206?
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 NCT06953206?
This trial is currently "Not Yet Recruiting." It started on 2026-03-01. The estimated completion date is 2037-09-30.
Who is sponsoring NCT06953206?
NCT06953206 is sponsored by Institut für Pharmakologie und Präventive Medizin. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06953206?
The trial aims to enroll 500 participants. The trial has not yet started recruiting.
How is NCT06953206 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06953206?
The primary outcome measures are: Early Safety (1-3 months); Device Success (1-3 months); Bioprosthetic Valve Failure (3-5 years); Bioprosthetic Valve Failure (9-10 years); Structural Valve Deterioration (9-10 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06953206 being conducted?
This trial is being conducted at 1 site, including Bad Oeynhausen, North Rhine-Westphalia (Germany).
Where can I find official information about NCT06953206?
The official record for NCT06953206 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06953206. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06953206 testing in simple terms?
This study will track how well a new type of artificial heart valve (SAPIEN 3 Ultra RESILIA) works in patients who have severe aortic stenosis. It is for adult patients (18+) who need a new aortic valve and will receive the SAPIEN 3 Ultra RESILIA valve through a minimally invasive procedure.
Why is this trial significant?
This trial matters because it will provide long-term data on the durability and performance of a new heart valve, potentially offering a more reliable option for patients with aortic stenosis.
What are the potential risks of participating in NCT06953206?
Potential risks include stroke, bleeding, heart attack, or complications related to the valve placement procedure. Some patients may require a permanent pacemaker or experience issues with the valve itself, such as embolization or obstruction. Long-term risks include the possibility of the bioprosthetic valve failing or deteriorating over time, requiring further intervention. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06953206?
Ask your doctor about the specific risks and benefits of the SAPIEN 3 Ultra RESILIA valve compared to other treatment options. Understand the commitment required for 10 years of follow-up appointments and what these visits will entail. Discuss how the valve replacement procedure will be performed and what to expect immediately after. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06953206 signal from an investment perspective?
This registry focuses on a specific, advanced heart valve, indicating a market for innovative cardiovascular devices and a commitment to long-term patient outcomes, suggesting potential for future mar 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 attending regular follow-up appointments for up to 10 years to monitor the valve's performance and your health. 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.