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

• Sponsor: Institut für Pharmakologie und Präventive Medizin (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04053088
• Collaborator: Edwards Lifesciences (Industry)
• Enrollment: 500
• Locations: 22
• Anticipated Duration (Months): 79.6
• Patients Per Site: 22.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Device: INSPIRIS RESILIA Aortic Valve™

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Surgical Aortic Valve Replacement: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.
• Actual Study Start Date: Dec 12, 2019
• Anticipated Primary Completion Date: Mar 1, 2026
• Anticipated Study Completion Date: Aug 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
SAVR patients patients undergoing surgical aortic valve replacement (SAVR) by usage of the INSPIRIS RESILIA Aortic valve™	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™

Outcome Measures

Primary Outcome Measures

1. All-cause mortality [after 1 year]

   All-cause mortality after 1 year will be investigated

2. All-cause mortality [after 3 years]

   All-cause mortality after 3 years will be investigated

3. All-cause mortality [after 5 years]

   All-cause mortality after 5 years will be investigated

Secondary Outcome Measures

1. Mortality [after 1 year]

   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

2. Mortality [after 3 years]

   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

3. Mortality [after 5 years]

   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

Other Outcome Measures

1. Change in Maximum pressure gradient (Pmax) over time [after 1 year]

   Change in Pmax in mmHg as an indicator of patient prosthesis mismatch

2. Change in Maximum pressure gradient (Pmax) over time [after 3 years]

   Change in Pmax in mmHg as an indicator of patient prosthesis mismatch

3. Change in Maximum pressure gradient (Pmax) over time [after 5 years]

   Change in Pmax in mmHg as an indicator of patient prosthesis mismatch

4. Change in mean pressure gradient (Pmean) over time [after 1 year]

   Change in Pmean in mmHg as an indicator of patient prosthesis mismatch

5. Change in mean pressure gradient (Pmean) over time [after 3 years]

   Change in Pmean in mmHg as an indicator of patient prosthesis mismatch

6. Change in mean pressure gradient (Pmean) over time [after 5 years]

   Change in Pmean in mmHg as an indicator of patient prosthesis mismatch

7. Change in velocity time integral (VTI) over time [after 1 year]

   Change in VTI as an indicator of patient prosthesis mismatch

8. Change in velocity time integral (VTI) over time [after 3 years]

   Change in VTI as an indicator of patient prosthesis mismatch

9. Change in velocity time integral (VTI) over time [after 5 years]

   Change in VTI as an indicator of patient prosthesis mismatch

10. Change in prostesis opening area (EOA) over time [after 1 year]

    Change in EOA in mm2 as an indicator of patient prosthesis mismatch

11. Change in prostesis opening area (EOA) over time [after 3 years]

    Change in EOA in mm2 as an indicator of patient prosthesis mismatch

12. Change in prostesis opening area (EOA) over time [after 5 years]

    Change in EOA in mm2 as an indicator of patient prosthesis mismatch

13. Change in left ventricular ejection fraction (LVEF) over time [after 1 year]

    Change in LVEF in % as an indicator of patient prosthesis mismatch

14. Change in left ventricular ejection fraction (LVEF) over time [after 3 years]

    Change in LVEF in % as an indicator of patient prosthesis mismatch

15. Change in left ventricular ejection fraction (LVEF) over time [after 5 years]

    Change in LVEF in % as an indicator of patient prosthesis mismatch

16. Occurence of paravalvular leaks [after 1 year]

    Occurence of paravalvular leaks as an indicator of patient prostheis mismatch

17. Occurence of paravalvular leaks [after 3 years]

    Occurence of paravalvular leaks as an indicator of patient prostheis mismatch

18. Occurence of paravalvular leaks [after 5 years]

    Occurence of paravalvular leaks as an indicator of patient prostheis mismatch

19. Occurence of structural valve detioration (SVD) over time [after 1 year]

    SVD to be determined by imaging methods (e.g. Echocardiography) following Salaun et al. 2018

20. Occurence of structural valve detioration (SVD) over time [after 3 years]

    SVD to be determined by imaging methods (e.g. Echocardiography) following Salaun et al. 2018

21. Occurence of structural valve detioration (SVD) over time [after 5 years]

    SVD to be determined by imaging methods (e.g. Echocardiography) following Salaun et al. 2018

22. Occurence of repeat procedures (valve-in-valve reoperation) [after 1 year]

    Any repeat procedures will be documented and assessed

23. Occurence of repeat procedures (valve-in-valve reoperation) [after 3 years]

    Any repeat procedures will be documented and assessed

24. Occurence of repeat procedures (valve-in-valve reoperation) [after 5 years]

    Any repeat procedures will be documented and assessed

25. New York Heart Association (NYHA) functional class compared to baseline [after 1 year]

    NYHA class will be determined at follow-up visits

26. New York Heart Association (NYHA) functional class compared to baseline [after 3 years]

    NYHA class will be determined at follow-up visits

27. New York Heart Association (NYHA) functional class compared to baseline [after 5 years]

    NYHA class will be determined at follow-up visits

28. Freedom from valve-related rehospitalization [after 1 year]

    any valve related hospitalizations will be documented and assessed

29. Freedom from valve-related rehospitalization [after 3 years]

    any valve related hospitalizations will be documented and assessed

30. Freedom from valve-related rehospitalization [after 5 years]

    any valve related hospitalizations will be documented and assessed

31. Need for new pacemaker implant [after 1 year]

    Any occurence of new pacemaker implant (e. g. when the participant did not have a pacemaker at baseline) will be documented and assessed

32. Need for new pacemaker implant [after 3 years]

    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

33. Need for new pacemaker implant [after 5 years]

    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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medizinische Universität Innsbruck, Uniklinik für Herzchirurgie	Innsbruck		Austria
2	Kepler Universitätsklinikum Linz	Linz		Austria	4021
3	• Universitätsklinikum Salzburg, Herzchirurgie, Gefäßchirurgie und endovaskuläre Chirurgie	Salzburg		Austria
4	• Klinikum Wels-Grieskirchen, Herz-, Gefäß- und Thoraxchirurgie	Wels		Austria
5	Klinikum Nürnberg	Nürnberg	Bayern	Germany	90471
6	Klinikum Passau/Universität Regensburg	Passau	Bayern	Germany	94032
7	Universitätsklinikum Würzburg	Würzburg	Bayern	Germany	97080
8	• Universitätsklinikum Frankfurt, Thorax-, Herz- und thorakale Gefässchirurgie	Frankfurt	Hessen	Germany	60590
9	Universitätsklinik für Herzchirurgie	Oldenburg	Niedersachsen	Germany	26133
10	Uniklinik RWTH Aachen	Aachen	NRW	Germany	52074
11	Schüchtermann Klinik	Bad Rothenfelde	NRW	Germany
12	Herzzentrum Bergmannsheil	Bochum	NRW	Germany	44789
13	Klinik für Herzchirurgie UKD	Düsseldorf	NRW	Germany	40225
14	Universitätsklinikum Essen	Essen	NRW	Germany	45147
15	• Universitätsklinikum Leipzig, Thorax- und Kardiovaskuläre Chirurgie	Leipzig	Sachsen	Germany	04103
16	BundeswehrKrankenhaus Klinik XVII und XVIII	Koblenz		Germany	56072
17	Helios Klinikum Siegburg	Siegburg		Germany	53721
18	Universitätsklinikum Ulm	Ulm		Germany	89091
19	Helios Klinikum Wuppertal	Wuppertal		Germany	42283
20	Catharina Ziekenhuis, Catharina Hart- en Vaatcentrum	Eindhoven		Netherlands
21	HerzKlinik Hirslanden, Herz- und thorakale Gefässchirurgie	Zürich		Switzerland
22	HerzZentrum Hirslanden, Herz- und Gefässchirurgie	Zürich		Switzerland

Sponsors and Collaborators

• Institut für Pharmakologie und Präventive Medizin
• Edwards Lifesciences

Investigators

• Principal Investigator: Farhad Bakhtiary, Dr. med., Helios Klinik Siegburg
• Principal Investigator: Andreas Zierer, Prof. Dr., Kepler University Hosiptal Linz and Hospital Wels-Grieskirchen

Study Documents (Full-Text)

None provided.

More Information

Publications

• Salaun E, Clavel MA, Rodés-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. Review.

• Responsible Party: Institut für Pharmakologie und Präventive Medizin
• ClinicalTrials.gov Identifier: NCT04053088
• Other Study ID Numbers: IPPM2019IMPACT
• First Posted: Aug 12, 2019
• Last Update Posted: Dec 21, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Institut für Pharmakologie und Präventive Medizin: Surgical Aortic Valve Replacement (SAVR); INSPIRIS RESILIA; Durability; Hemodynamics
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Dec 21, 2021