Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.

Aortic Valve Stenosis Clinical Trial

Official title:

Title Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06420830
• Other study ID #: RESILIA
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: September 1, 2034

Study information

• Verified date: May 2024
• Source: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Contact: Josep Rodés-Cabau, MD
• Phone: 4186568711
• Email: josep.rodes[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity burden. The SAPIEN 3 Ultra RESILIA valve represents the last generation of the SAPIEN valve system and includes several important iterations (newer leaflet calcium-blocking technology targeting calcium-attracting free aldehydes, dry tissue storage, newer skirt textile design) that should translate into a favorable impact on valve durability at mid- to long- term follow-up

Description:

Prospective observational registry including patients with severe aortic stenosis undergoing TAVR with the SAPIEN 3 Ultra RESILIA valve. All patients who will survive the procedure will undergo a clinical and echocardiographic follow-up at 1-3 months (± 15 days), at 1-year (±30 days), 3-5 year (±30 days), 6-8 year (±30 days) and 9-10 year (±30 days) after valve implantation. Transthoracic echocardiography (TTE) exams (baseline, 1-3-month, 1 year, 3-5 years, 6-8 years, and 9-10 years post-procedure) will be evaluated in a Centralized Echocardiographic Core Lab at the Quebec Heart and Lung Institute. The measurements obtained in the Core Lab regarding transvalvular gradient, EOA, PPM and PVL at 1-3 months will determine the primary outcome of the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 1, 2034
• Est. primary completion date: September 1, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria - Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.
• Successful valve implantation of the SAPIEN 3 Ultra RESILIA valve.

VARC-3- defined technical success defined as:

• Freedom from mortality
• Successful access, delivery of the device, and retrieval of the delivery system
• Correct positioning of a single prosthetic heart valve into the proper anatomical location
• Freedom from surgery or intervention related to the device (excluding permanent pacemaker) or to a major vascular or access related, or cardiac structural complication - Absence of severe procedural or in-hospital complications (VARC-3 definitions): mortality, stroke, bleeding type 2-4, myocardial infarction, need for a second valve, valve embolization, coronary obstruction, annular rupture.

Exclusion Criteria:

• Age >80 years
• Severe pulmonary disease (FEV1 <50% predicted or need for home oxygen)
• Severe renal dysfunction (eGFR <30 ml/min/1.73m2)
• Frailty (Clinical Frailty Scale > 4)
• Severe coronary disease (SYNTAX score >32)
• Left ventricular ejection fraction =30%
• Moderate-to-severe mitral regurgitation
• Severe tricuspid regurgitation
• Pulmonary systolic pressure >60 mmHg
• STS-PROM >5%
• Any disease leading to a life expectancy <5 years

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Transcatheter Aortic Valve Replacement

Intervention

Procedure:
• SAPIEN 3 Ultra RESILIA Valve
Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.

Locations

Country	Name	City	State
Canada	IUCPQ	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Ferreira-Neto AN, Rodriguez-Gabella T, Guimaraes L, Freitas-Ferraz A, Bernier M, Figueiredo Guimaraes C, Pasian S, Paradis JM, Delarochelliere R, Dumont E, Mohammadi S, Kalavrouziotis D, Cote M, Pibarot P, Rodes-Cabau J. Multimodality evaluation of transcatheter structural valve degeneration at long-term follow-up. Rev Esp Cardiol (Engl Ed). 2021 Mar;74(3):247-256. doi: 10.1016/j.rec.2020.02.002. Epub 2020 Apr 8. English, Spanish. — View Citation

Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22. — View Citation

Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16. — View Citation

Montarello NJ, Willemen Y, Tirado-Conte G, Travieso A, Bieliauskas G, Sondergaard L, De Backer O. Transcatheter aortic valve durability: a contemporary clinical review. Front Cardiovasc Med. 2023 May 9;10:1195397. doi: 10.3389/fcvm.2023.1195397. eCollection 2023. — View Citation

Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16. — View Citation

Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available. Erratum In: Eur Heart J. 2022 Feb 18;: — View Citation

Writing Committee Members; Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C; ACC/AHA Joint Committee Members; O'Gara PT, Beckman JA, Levine GN, Al-Khatib SM, Armbruster A, Birtcher KK, Ciggaroa J, Deswal A, Dixon DL, Fleisher LA, de Las Fuentes L, Gentile F, Goldberger ZD, Gorenek B, Haynes N, Hernandez AF, Hlatky MA, Joglar JA, Jones WS, Marine JE, Mark D, Palaniappan L, Piano MR, Spatz ES, Tamis-Holland J, Wijeysundera DN, Woo YJ. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Thorac Cardiovasc Surg. 2021 Aug;162(2):e183-e353. doi: 10.1016/j.jtcvs.2021.04.002. Epub 2021 May 8. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transvalvular gradient	Residual (peak and mean) transvalvular gradient	1-3 months
Primary	Effective orifice area (EOA)	EOA evaluated by echocardiography imaging	1-3 months
Primary	Prosthesis-patient mismatch	Moderate or severe prothesis-patient mismatch (defines as an index aortic valve area 0.85-0.66 cm2/m2 (moderate), =0.65 cm2/m2 (severe) for patient with BMI ?30km/m2 and 0.70-0.56 cm2/m2 (moderate), =0.55 cm2/m2 (severe) for patient with BMI =30km/m2 and/or moderate-severe aortic regurgitation (AR) (VARC-3 definition).	1-3 months
Primary	Paravalvular leaks	Paravalvular leaks evaluated by echocardiography imaging	1-3 months
Secondary	Transvalvular gradient	Residual (maximal and mean) transvalvular gradient	1-, 3-5-, 6-8-, and 9-10-year follow-up.
Secondary	Effective orifice area (EOA)	EOA evaluated by echocardiography imaging	1-, 3-5-, 6-8-, and 9-10-year follow-up.
Secondary	Bioprosthetic valve dysfunction	Bioprosthetic valve dysfunction evaluated by VARC3 criteria	1-, 3-5-, 6-8-, and 9-10-year follow-up.
Secondary	Paravalvular leaks	Paravalvular leaks evaluated by echocardiography imaging	1-, 3-5-, 6-8-, and 9-10-year follow-up.
Secondary	Bioprosthetic valve dysfunction	Incidence rate (per 100 patient-years) of bioprosthetic valve dysfunction (stage 2 or 3)	yearly
Secondary	Bioprosthetic valve failure	Incidence rate (per 100 patient-years) of bioprosthetic valve failure	yearly
Secondary	Bioprosthetic valve failure	Bioprosthetic valve failure evaluated by VARC3 criteria	1-, 3-5-, 6-8-, and 9-10-year follow-up.
Secondary	Clinical events	Individual: mortality, stroke, bleeding type 2-4, cardiac rehospitalization, heart failure rehospitalization	1month and yearly up to 10-year
Secondary	Valve thrombosis	Number of patients with valve thrombosis	1-3 months and yearly up to 10-year
Secondary	Valve endocarditis	Number of patients with valve endocarditis	1-3 months and yearly up to 10-year