Clinical trial NCT04053088: SAVR: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.
Official title: Surgical Aortic Valve Replacement: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiovascular Diseases
Keywords: Surgical Aortic Valve Replacement (SAVR)
INSPIRIS RESILIA
Durability
Hemodynamics
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
Collaborators: name: Edwards Lifesciences
First posted: 2019-08-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: The INSPIRIS RESILIA Aortic Valve™ is a stented tri-leaflet valve comprised of bovine pericardial tissue. The tissue is created by treating bovine pericardial tissue with Edwards Integrity Preservation. It incorporates a stable capping anticalcification process, which blocks residual aldehyde groups known to bind with calcium. Tissue preservation with glycerol allows the valve to be stored without a traditional liquid-based solution, such as glutaraldehyde. Therefore, valve is stored under dry packaging conditions and consequently does not require rinsing prior to implantation.

The novel tissue preservation technology significantly improves hemodynamic and anticalcification properties compared with the standard Perimount valve in an ovine model (Flameng et al., 2015). The RESILIA tissue has been studied in the COMMENCE trial: Two year data show that the NYHA class improved in 65.7% of patients, effective orifice area after implantation was 1.6 ± 0.5 cm2; mean gradient was 10.1 ± 4.3 mmHg; and paravalvular leak was none/trivial in 94.5% of patients (mild to moderate in 0.5%) (Puskas et al., 2017).

On the sizes 19 - 25 mm the INSPIRIS RESILIA Aortic Valve™ has been outfitted with the VFit technology, which incorporates two novel features designed for potential future valve-in-valve procedures: fluoroscopically visible size markers and an expandable cobalt chromium alloy band. No clinical data are available that evaluate the use of the INSPIRIS RESILIA Aortic Valve™ in patients to date.

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

Primary outcomes:
measure: All-cause mortality
timeFrame: after 1 year
measure: All-cause mortality
timeFrame: after 3 years
measure: All-cause mortality
timeFrame: after 5 years
Secondary outcomes:
measure: Mortality
timeFrame: after 1 year
measure: Mortality
timeFrame: after 3 years
measure: Mortality
timeFrame: after 5 years
Other outcomes:
measure: Change in Maximum pressure gradient (Pmax) over time
timeFrame: after 1 year
measure: Change in Maximum pressure gradient (Pmax) over time
timeFrame: after 3 years
measure: Change in Maximum pressure gradient (Pmax) over time
timeFrame: after 5 years
measure: Change in mean pressure gradient (Pmean) over time
timeFrame: after 1 year
measure: Change in mean pressure gradient (Pmean) over time
timeFrame: after 3 years
measure: Change in mean pressure gradient (Pmean) over time
timeFrame: after 5 years
measure: Change in velocity time integral (VTI) over time
timeFrame: after 1 year
measure: Change in velocity time integral (VTI) over time
timeFrame: after 3 years
measure: Change in velocity time integral (VTI) over time
timeFrame: after 5 years
measure: Change in prostesis opening area (EOA) over time
timeFrame: after 1 year
measure: Change in prostesis opening area (EOA) over time
timeFrame: after 3 years
measure: Change in prostesis opening area (EOA) over time
timeFrame: after 5 years
measure: Change in left ventricular ejection fraction (LVEF) over time
timeFrame: after 1 year
measure: Change in left ventricular ejection fraction (LVEF) over time
timeFrame: after 3 years
measure: Change in left ventricular ejection fraction (LVEF) over time
timeFrame: after 5 years
measure: Occurence of paravalvular leaks
timeFrame: after 1 year
measure: Occurence of paravalvular leaks
timeFrame: after 3 years
measure: Occurence of paravalvular leaks
timeFrame: after 5 years
measure: Occurence of structural valve detioration (SVD) over time
timeFrame: after 1 year
measure: Occurence of structural valve detioration (SVD) over time
timeFrame: after 3 years
measure: Occurence of structural valve detioration (SVD) over time
timeFrame: after 5 years
measure: Occurence of repeat procedures (valve-in-valve reoperation)
timeFrame: after 1 year
measure: Occurence of repeat procedures (valve-in-valve reoperation)
timeFrame: after 3 years
measure: Occurence of repeat procedures (valve-in-valve reoperation)
timeFrame: after 5 years
measure: New York Heart Association (NYHA) functional class compared to baseline
timeFrame: after 1 year
measure: New York Heart Association (NYHA) functional class compared to baseline
timeFrame: after 3 years
measure: New York Heart Association (NYHA) functional class compared to baseline
timeFrame: after 5 years
measure: Freedom from valve-related rehospitalization
timeFrame: after 1 year
measure: Freedom from valve-related rehospitalization
timeFrame: after 3 years
measure: Freedom from valve-related rehospitalization
timeFrame: after 5 years
measure: Need for new pacemaker implant
timeFrame: after 1 year
measure: Need for new pacemaker implant
timeFrame: after 3 years
measure: Need for new pacemaker implant
timeFrame: after 5 years
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck, Uniklinik für Herzchirurgie
city: Linz
country: Austria
facility: Kepler Universitätsklinikum Linz
city: Salzburg
country: Austria
facility: • Universitätsklinikum Salzburg, Herzchirurgie, Gefäßchirurgie und endovaskuläre Chirurgie
city: Wels
country: Austria
facility: • Klinikum Wels-Grieskirchen, Herz-, Gefäß- und Thoraxchirurgie
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
state: Bayern
city: Passau
country: Germany
facility: Klinikum Passau/Universität Regensburg
state: Bayern
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
state: Bayern
city: Frankfurt
country: Germany
facility: • Universitätsklinikum Frankfurt, Thorax-, Herz- und thorakale Gefässchirurgie
state: Hessen
city: Oldenburg
country: Germany
facility: Universitätsklinik für Herzchirurgie
state: Niedersachsen
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen
state: NRW
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann Klinik
state: NRW
city: Bochum
country: Germany
facility: Herzzentrum Bergmannsheil
state: NRW
city: Düsseldorf
country: Germany
facility: Klinik für Herzchirurgie UKD
state: NRW
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: NRW
city: Leipzig
country: Germany
facility: • Universitätsklinikum Leipzig, Thorax- und Kardiovaskuläre Chirurgie
state: Sachsen
city: Koblenz
country: Germany
facility: BundeswehrKrankenhaus Klinik XVII und XVIII
city: Siegburg
country: Germany
facility: Helios Klinikum Siegburg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Wuppertal
country: Germany
facility: Helios Klinikum Wuppertal
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis, Catharina Hart- en Vaatcentrum
city: Zürich
country: Switzerland
facility: HerzKlinik Hirslanden, Herz- und thorakale Gefässchirurgie
city: Zürich
country: Switzerland
facility: HerzZentrum Hirslanden, Herz- und Gefässchirurgie
Study officials:
affiliation: Helios Klinik Siegburg
name: Farhad Bakhtiary, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kepler University Hosiptal Linz and Hospital Wels-Grieskirchen
name: Andreas Zierer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salaun E, Clavel MA, Rodes-Cabau J, Pibarot P. Bioprosthetic aortic valve durability in the era of transcatheter aortic valve implantation. Heart. 2018 Aug;104(16):1323-1332. doi: 10.1136/heartjnl-2017-311582. Epub 2018 May 7.
citation: Bakhtiary F, Ahmad AE, Autschbach R, Benedikt P, Bonaros N, Borger M, Dewald O, Feyrer R, Geissler HJ, Grunenfelder J, Lam KY, Leyh R, Liebold A, Czesla M, Mehdiani A, Pollari F, Salamate S, Strauch J, Votsch A, Weber A, Wendt D, Botta B, Bramlage P, Zierer A. Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement - rationale and design of the international IMPACT registry. J Cardiothorac Surg. 2021 Mar 25;16(1):51. doi: 10.1186/s13019-021-01434-w.