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Can a Patient's other health problems predict how well a new aortic valve performs?

NCT ID NCT04053088

Knowledge-focused Sponsor: Institut für Pharmakologie und Präventive Medizin Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This registry follows 500 people receiving a specific type of surgical aortic valve replacement (the INSPIRIS RESILIA valve) for up to five years. Researchers are tracking how pre-existing conditions like kidney disease, diabetes, and high blood pressure affect survival and valve function. The goal is to understand real-world outcomes and identify which patient groups may need closer monitoring.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Edwards INSPIRIS RESILIA Aortic Valve
What this could lead to
If successful, this registry could help doctors better predict which patients are at higher risk after aortic valve surgery and improve long-term care.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by differences in patient health and care across centers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Minimum of 500 patients (20 patients per center) undergoing Surgical Aortic Valve Replacement (SAVR) using the INSPIRIS RESILIA aortic valve™ (all comers). The required sample size was calculated using the online calculator at http://www.surveysystem.com/sscalc.htm. It was estimated, from the COMMENCE Trial dataset (Puskas et al., 2017) that all-cause mortality is around 1.2% at year 1 and 2.0% at year 2.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient is at least 18 years old 2. Patient has an aortic valve vitium and requires an aortic valve replacement with the Edwards INSPIRIS RESILIA Aortic Valve™ 3. Patient is scheduled to attend yearly follow-up visits at the registry center up to 5 years 4. Patient provides written informed consent prior to the procedure and in case of emergency after the procedure. Exclusion Criteria: 1. Disability and / or other circumstances under which the patient is not capable to understand the nature, significance and scope of the clinical trial 2. Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery 3. Patient has a life expectancy ≤ 12 months for any reason 4. Valve implantation is not possible in accordance with the device IFU 5. Pregnancy

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Conditions

The condition(s) this trial relates to.

aortic valve disorder cardiovascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases

Contacts and locations

Locations

  • BundeswehrKrankenhaus Klinik XVII und XVIII

    Koblenz, 56072, Germany

  • Catharina Ziekenhuis, Catharina Hart- en Vaatcentrum

    Eindhoven, Netherlands

  • Helios Klinikum Siegburg

    Siegburg, 53721, Germany

  • Helios Klinikum Wuppertal

    Wuppertal, 42283, Germany

  • HerzKlinik Hirslanden, Herz- und thorakale Gefässchirurgie

    Zurich, Switzerland

  • HerzZentrum Hirslanden, Herz- und Gefässchirurgie

    Zurich, Switzerland

  • Herzzentrum Bergmannsheil

    Bochum, North Rhine-Westphalia, 44789, Germany

  • Kepler Universitätsklinikum Linz

    Linz, 4021, Austria

  • Klinik für Herzchirurgie UKD

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Klinikum Nürnberg

    Nuremberg, Bavaria, 90471, Germany

  • Klinikum Passau/Universität Regensburg

    Passau, Bavaria, 94032, Germany

  • Medizinische Universität Innsbruck, Uniklinik für Herzchirurgie

    Innsbruck, Austria

  • Schüchtermann Klinik

    Bad Rothenfelde, North Rhine-Westphalia, Germany

  • Uniklinik RWTH Aachen

    Aachen, North Rhine-Westphalia, 52074, Germany

  • Universitätsklinik für Herzchirurgie

    Oldenburg, Lower Saxony, 26133, Germany

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitätsklinikum Ulm

    Ulm, 89091, Germany

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080, Germany

  • • Klinikum Wels-Grieskirchen, Herz-, Gefäß- und Thoraxchirurgie

    Wels, Austria

  • • Universitätsklinikum Frankfurt, Thorax-, Herz- und thorakale Gefässchirurgie

    Frankfurt am Main, Hesse, 60590, Germany

  • • Universitätsklinikum Leipzig, Thorax- und Kardiovaskuläre Chirurgie

    Leipzig, Saxony, 04103, Germany

  • • Universitätsklinikum Salzburg, Herzchirurgie, Gefäßchirurgie und endovaskuläre Chirurgie

    Salzburg, Austria

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