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

Cardiovascular Diseases Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04053088
• Other study ID #: IPPM2019IMPACT
• Status: Active, not recruiting
• Start date: December 12, 2019
• Est. completion date: August 1, 2026

Study information

• Verified date: April 2024
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: August 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Device:
• INSPIRIS RESILIA Aortic Valve™
Collection of patient data from patients undergoing Surgical Aortic Valve Replacement (SAVR) by usage of the INSPIRIS RESILIA aortic valve™

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck, Uniklinik für Herzchirurgie	Innsbruck
Austria	Kepler Universitätsklinikum Linz	Linz
Austria	• Universitätsklinikum Salzburg, Herzchirurgie, Gefäßchirurgie und endovaskuläre Chirurgie	Salzburg
Austria	• Klinikum Wels-Grieskirchen, Herz-, Gefäß- und Thoraxchirurgie	Wels
Germany	Uniklinik RWTH Aachen	Aachen	NRW
Germany	Schüchtermann Klinik	Bad Rothenfelde	NRW
Germany	Herzzentrum Bergmannsheil	Bochum	NRW
Germany	Klinik für Herzchirurgie UKD	Düsseldorf	NRW
Germany	Universitätsklinikum Essen	Essen	NRW
Germany	• Universitätsklinikum Frankfurt, Thorax-, Herz- und thorakale Gefässchirurgie	Frankfurt	Hessen
Germany	BundeswehrKrankenhaus Klinik XVII und XVIII	Koblenz
Germany	• Universitätsklinikum Leipzig, Thorax- und Kardiovaskuläre Chirurgie	Leipzig	Sachsen
Germany	Klinikum Nürnberg	Nürnberg	Bayern
Germany	Universitätsklinik für Herzchirurgie	Oldenburg	Niedersachsen
Germany	Klinikum Passau/Universität Regensburg	Passau	Bayern
Germany	Helios Klinikum Siegburg	Siegburg
Germany	Universitätsklinikum Ulm	Ulm
Germany	Helios Klinikum Wuppertal	Wuppertal
Germany	Universitätsklinikum Würzburg	Würzburg	Bayern
Netherlands	Catharina Ziekenhuis, Catharina Hart- en Vaatcentrum	Eindhoven
Switzerland	HerzKlinik Hirslanden, Herz- und thorakale Gefässchirurgie	Zürich
Switzerland	HerzZentrum Hirslanden, Herz- und Gefässchirurgie	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin	Edwards Lifesciences

Countries where clinical trial is conducted

Austria,  Germany,  Netherlands,  Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Maximum pressure gradient (Pmax) over time	Change in Pmax in mmHg as an indicator of patient prosthesis mismatch	after 1 year
Other	Change in Maximum pressure gradient (Pmax) over time	Change in Pmax in mmHg as an indicator of patient prosthesis mismatch	after 3 years
Other	Change in Maximum pressure gradient (Pmax) over time	Change in Pmax in mmHg as an indicator of patient prosthesis mismatch	after 5 years
Other	Change in mean pressure gradient (Pmean) over time	Change in Pmean in mmHg as an indicator of patient prosthesis mismatch	after 1 year
Other	Change in mean pressure gradient (Pmean) over time	Change in Pmean in mmHg as an indicator of patient prosthesis mismatch	after 3 years
Other	Change in mean pressure gradient (Pmean) over time	Change in Pmean in mmHg as an indicator of patient prosthesis mismatch	after 5 years
Other	Change in velocity time integral (VTI) over time	Change in VTI as an indicator of patient prosthesis mismatch	after 1 year
Other	Change in velocity time integral (VTI) over time	Change in VTI as an indicator of patient prosthesis mismatch	after 3 years
Other	Change in velocity time integral (VTI) over time	Change in VTI as an indicator of patient prosthesis mismatch	after 5 years
Other	Change in prostesis opening area (EOA) over time	Change in EOA in mm2 as an indicator of patient prosthesis mismatch	after 1 year
Other	Change in prostesis opening area (EOA) over time	Change in EOA in mm2 as an indicator of patient prosthesis mismatch	after 3 years
Other	Change in prostesis opening area (EOA) over time	Change in EOA in mm2 as an indicator of patient prosthesis mismatch	after 5 years
Other	Change in left ventricular ejection fraction (LVEF) over time	Change in LVEF in % as an indicator of patient prosthesis mismatch	after 1 year
Other	Change in left ventricular ejection fraction (LVEF) over time	Change in LVEF in % as an indicator of patient prosthesis mismatch	after 3 years
Other	Change in left ventricular ejection fraction (LVEF) over time	Change in LVEF in % as an indicator of patient prosthesis mismatch	after 5 years
Other	Occurence of paravalvular leaks	Occurence of paravalvular leaks as an indicator of patient prostheis mismatch	after 1 year
Other	Occurence of paravalvular leaks	Occurence of paravalvular leaks as an indicator of patient prostheis mismatch	after 3 years
Other	Occurence of paravalvular leaks	Occurence of paravalvular leaks as an indicator of patient prostheis mismatch	after 5 years
Other	Occurence of structural valve detioration (SVD) over time	SVD to be determined by imaging methods (e.g. Echocardiography) following Salaun et al. 2018	after 1 year
Other	Occurence of structural valve detioration (SVD) over time	SVD to be determined by imaging methods (e.g. Echocardiography) following Salaun et al. 2018	after 3 years
Other	Occurence of structural valve detioration (SVD) over time	SVD to be determined by imaging methods (e.g. Echocardiography) following Salaun et al. 2018	after 5 years
Other	Occurence of repeat procedures (valve-in-valve reoperation)	Any repeat procedures will be documented and assessed	after 1 year
Other	Occurence of repeat procedures (valve-in-valve reoperation)	Any repeat procedures will be documented and assessed	after 3 years
Other	Occurence of repeat procedures (valve-in-valve reoperation)	Any repeat procedures will be documented and assessed	after 5 years
Other	New York Heart Association (NYHA) functional class compared to baseline	NYHA class will be determined at follow-up visits	after 1 year
Other	New York Heart Association (NYHA) functional class compared to baseline	NYHA class will be determined at follow-up visits	after 3 years
Other	New York Heart Association (NYHA) functional class compared to baseline	NYHA class will be determined at follow-up visits	after 5 years
Other	Freedom from valve-related rehospitalization	any valve related hospitalizations will be documented and assessed	after 1 year
Other	Freedom from valve-related rehospitalization	any valve related hospitalizations will be documented and assessed	after 3 years
Other	Freedom from valve-related rehospitalization	any valve related hospitalizations will be documented and assessed	after 5 years
Other	Need for new pacemaker implant	Any occurence of new pacemaker implant (e. g. when the participant did not have a pacemaker at baseline) will be documented and assessed	after 1 year
Other	Need for new pacemaker implant	Any occurence of new pacemaker implant (e. g. when the participant did not have a pacemaker at the preceding follow-up visit) will be documented and assessed	after 3 years
Other	Need for new pacemaker implant	Any occurence of new pacemaker implant (e. g. when the participant did not have a pacemaker at the preceding follow-up visit) will be documented and assessed	after 5 years
Primary	All-cause mortality	All-cause mortality after 1 year will be investigated	after 1 year
Primary	All-cause mortality	All-cause mortality after 3 years will be investigated	after 3 years
Primary	All-cause mortality	All-cause mortality after 5 years will be investigated	after 5 years
Secondary	Mortality	All cause, cardiac and valve-related mortality in the overall study population and in different patient subgroups at all timepoints: Chronic kidney disease, diabetes, hypertension, metabolic syndrome, inflammation	after 1 year
Secondary	Mortality	All cause, cardiac and valve-related mortality in the overall study population and in different patient subgroups at all timepoints: Chronic kidney disease, diabetes, hypertension, metabolic syndrome, inflammation	after 3 years
Secondary	Mortality	All cause, cardiac and valve-related mortality in the overall study population and in different patient subgroups at all timepoints: Chronic kidney disease, diabetes, hypertension, metabolic syndrome, inflammation	after 5 years