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SAVR: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.

NCT04053088

Active Not RecruitingN/A

Sponsor: Institut für Pharmakologie und Präventive Medizin

Conditions: Cardiovascular Diseases

Interventions: INSPIRIS RESILIA Aortic Valve™

Countries: Austria, Germany, Netherlands, Switzerland

The IMPACT Registry represents a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years that includes data of patients undergoing aortic valve replacement with the Edwards INSPIRIS RESILIA Aortic Valve™. The IMPACT Registry will be performed in up to 25 participating sites across Germany, Austria and Switzerland. A minimum number of 500 patients (20 patients per center) will be enrolled. Patients will undergo follow-up visits at baseline, surgery, pre-discharge, year 1, year 3 and year 5.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (22)

Innsbruck, Austria
Linz, Austria
Salzburg, Austria
Wels, Austria
Nuremberg, Bavaria, Germany
Passau, Bavaria, Germany
Würzburg, Bavaria, Germany
Frankfurt am Main, Hesse, Germany
Oldenburg, Lower Saxony, Germany
Aachen, North Rhine-Westphalia, Germany
Bad Rothenfelde, North Rhine-Westphalia, Germany
Bochum, North Rhine-Westphalia, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Leipzig, Saxony, Germany
Koblenz, Germany
Siegburg, Germany
Ulm, Germany
Wuppertal, Germany
Eindhoven, Netherlands
Zurich, Switzerland
Zurich, Switzerland