## Protocol Section
### Identification Module
**NCT ID:** NCT06420830

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

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

#### Organization Study ID Info
**ID:** RESILIA
#### Organization
**Class:** OTHER
**Full Name:** Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
### Status Module
#### Completion Date
**Date:** 2034-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

#### Responsible Party

**Investigator Affiliation:** Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

**Investigator Full Name:** Josep Rodes-Cabau

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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

**Detailed 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.

### Conditions Module

**Conditions:**

- Aortic Valve Stenosis

- Transcatheter Aortic Valve Replacement

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.

**Name:** SAPIEN 3 Ultra RESILIA Valve

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Residual (peak and mean) transvalvular gradient

**Measure:** Transvalvular gradient

**Time Frame:** 1-3 months

**Description:** EOA evaluated by echocardiography imaging

**Measure:** Effective orifice area (EOA)

**Time Frame:** 1-3 months

**Description:** 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).

**Measure:** Prosthesis-patient mismatch

**Time Frame:** 1-3 months

**Description:** Paravalvular leaks evaluated by echocardiography imaging

**Measure:** Paravalvular leaks

**Time Frame:** 1-3 months

#### Secondary Outcomes

**Description:** Residual (maximal and mean) transvalvular gradient

**Measure:** Transvalvular gradient

**Time Frame:** 1-, 3-5-, 6-8-, and 9-10-year follow-up.

**Description:** EOA evaluated by echocardiography imaging

**Measure:** Effective orifice area (EOA)

**Time Frame:** 1-, 3-5-, 6-8-, and 9-10-year follow-up.

**Description:** Bioprosthetic valve dysfunction evaluated by VARC3 criteria

**Measure:** Bioprosthetic valve dysfunction

**Time Frame:** 1-, 3-5-, 6-8-, and 9-10-year follow-up.

**Description:** Paravalvular leaks evaluated by echocardiography imaging

**Measure:** Paravalvular leaks

**Time Frame:** 1-, 3-5-, 6-8-, and 9-10-year follow-up.

**Description:** Incidence rate (per 100 patient-years) of bioprosthetic valve dysfunction (stage 2 or 3)

**Measure:** Bioprosthetic valve dysfunction

**Time Frame:** yearly

**Description:** Incidence rate (per 100 patient-years) of bioprosthetic valve failure

**Measure:** Bioprosthetic valve failure

**Time Frame:** yearly

**Description:** Bioprosthetic valve failure evaluated by VARC3 criteria

**Measure:** Bioprosthetic valve failure

**Time Frame:** 1-, 3-5-, 6-8-, and 9-10-year follow-up.

**Description:** Individual: mortality, stroke, bleeding type 2-4, cardiac rehospitalization, heart failure rehospitalization

**Measure:** Clinical events

**Time Frame:** 1month and yearly up to 10-year

**Description:** Number of patients with valve thrombosis

**Measure:** Valve thrombosis

**Time Frame:** 1-3 months and yearly up to 10-year

**Description:** Number of patients with valve endocarditis

**Measure:** Valve endocarditis

**Time Frame:** 1-3 months and yearly up to 10-year

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Population Patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra RESILIA valve.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** josep.rodes@criucpq.ulaval.ca

**Name:** Josep Rodés-Cabau, MD

**Phone:** 4186568711

**Role:** CONTACT

**Contact 2:**

**Email:** emilie.pelletier-beaumont@criucpq.ulaval.ca

**Name:** Emilie Pelletier beaumont, MSc

**Phone:** 418-656-8711

**Phone Ext:** 3929

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Quebec

**Country:** Canada

**Facility:** IUCPQ

**Zip:** G1V 4G5

#### Overall Officials

**Official 1:**

**Affiliation:** IUCPQ-UL

**Name:** Josep Rodés-Cabau, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Fondation IUCPQ

**Name:** Emilie Pelletier beaumont, MSc

**Role:** STUDY_DIRECTOR

### References Module

#### References

**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.

**PMID:** 33972115

**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;:

**PMID:** 34453165

**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.

**PMID:** 30883058

**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.

**PMID:** 30883053

**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.

**PMID:** 37229228

**Citation:** 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.

**PMID:** 32278660

**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.

**PMID:** 20961243

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000082862

- Term: Aortic Valve Disease

- ID: D000006349

- Term: Heart Valve Diseases

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014694

- Term: Ventricular Outflow Obstruction

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M4340

- Name: Aortic Valve Stenosis

- Relevance: HIGH

- As Found: Aortic Valve Stenosis

- ID: M2379

- Name: Aortic Valve Disease

- Relevance: LOW

- As Found: Unknown

- ID: M9437

- Name: Heart Valve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17440

- Name: Ventricular Outflow Obstruction

- Relevance: LOW

- As Found: Unknown

- ID: T449

- Name: Aortic Valve Stenosis

- Relevance: HIGH

- As Found: Aortic Valve Stenosis

### Condition Browse Module - Meshes

- ID: D000001024

- Term: Aortic Valve Stenosis

### Misc Info Module

- Version Holder: 2024-05-31
