Aortic Valve StenosisNCT06420830

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

An observational study of Aortic Valve Stenosis and Transcatheter Aortic Valve Replacement, run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
What is being tested?: SAPIEN 3 Ultra RESILIA Valve
Type of treatment: Surgery or procedure
How many people: 150 participants
Where: 1 siteCanada
Study dates: 16 May 2024to 1 Sep 2034
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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%

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Josep Rodés-Cabau, MD contact

4186568711

josep.rodes@criucpq.ulaval.ca

Emilie Pelletier beaumont, MSc contact

418-656-8711 ext. 3929

emilie.pelletier-beaumont@criucpq.ulaval.ca

Canada1 site, 1 recruiting

IUCPQ
Québec, Quebec, G1V 4G5
Josep Rodes-Cabau, MD, 418-656-8711, josep.rodes@criucpq.ulaval.ca
Emilie Pelletier Beaumont, MSc, 418-656-8711, emilie.pelletier-beaumont@criucpq.ulaval.ca
Recruiting

Other trials in Canada

About this study

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

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

Read the 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: Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Being tested: SAPIEN 3 Ultra RESILIA Valve
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SAPIEN 3 Ultra RESILIA ValveProcedure or surgery
Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.

What is being measured

The primary outcome is the main question the study is designed to answer.

Transvalvular gradient
Residual (peak and mean) transvalvular gradient
Measured: 1-3 months
Effective orifice area (EOA)
EOA evaluated by echocardiography imaging
Measured: 1-3 months
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).
Measured: 1-3 months
Paravalvular leaks
Paravalvular leaks evaluated by echocardiography imaging
Measured: 1-3 months

Secondary outcomes (10)

Transvalvular gradient
Residual (maximal and mean) transvalvular gradient
Measured: 1-, 3-5-, 6-8-, and 9-10-year follow-up.
Effective orifice area (EOA)
EOA evaluated by echocardiography imaging
Measured: 1-, 3-5-, 6-8-, and 9-10-year follow-up.
Bioprosthetic valve dysfunction
Bioprosthetic valve dysfunction evaluated by VARC3 criteria
Measured: 1-, 3-5-, 6-8-, and 9-10-year follow-up.
Paravalvular leaks
Paravalvular leaks evaluated by echocardiography imaging
Measured: 1-, 3-5-, 6-8-, and 9-10-year follow-up.
Bioprosthetic valve dysfunction
Incidence rate (per 100 patient-years) of bioprosthetic valve dysfunction (stage 2 or 3)
Measured: yearly
Bioprosthetic valve failure
Incidence rate (per 100 patient-years) of bioprosthetic valve failure
Measured: yearly
Bioprosthetic valve failure
Bioprosthetic valve failure evaluated by VARC3 criteria
Measured: 1-, 3-5-, 6-8-, and 9-10-year follow-up.
Clinical events
Individual: mortality, stroke, bleeding type 2-4, cardiac rehospitalization, heart failure rehospitalization
Measured: 1month and yearly up to 10-year
Valve thrombosis
Number of patients with valve thrombosis
Measured: 1-3 months and yearly up to 10-year
Valve endocarditis
Number of patients with valve endocarditis
Measured: 1-3 months and yearly up to 10-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 20241 Sep 2034

First posted20 May 2024
Study start16 May 2024
Primary completion1 Oct 2027 (estimated)
Study completion1 Sep 2034 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06420830
Sponsor's protocol ID: RESILIA
Status last verified: Nov 2026
First submitted: 15 May 2024
Last updated: 4 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 33972115
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.
PubMed 34453165
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.
PubMed 30883058
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.
PubMed 30883053
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.
PubMed 37229228
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.
PubMed 32278660
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.
PubMed 20961243

Interested in taking part?

Josep Rodés-Cabau, MD

4186568711

josep.rodes@criucpq.ulaval.ca

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Title Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
ClinicalTrials.gov ID: NCT06420830
Acronym / sponsor ID: RESILIA
Conditions: Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Study type: Observational
Recruitment status: Recruiting
Enrolment: 150 participants (estimated)
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University LavalUniversity, hospital or other
Study start: 16 May 2024 (actual)
Primary completion: 1 Oct 2027 (estimated)
Study completion: 1 Sep 2034 (estimated)
First posted: 20 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 80 years
Sex: All
Age groups: Adult, Older adult
Study population: Population Patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra RESILIA valve.

Key inclusion criteria (7 listed)

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.
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

Key exclusion criteria (11 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SAPIEN 3 Ultra RESILIA ValvePatients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.	Procedure or surgery	–

Primary outcome

Transvalvular gradient
Time frame: 1-3 months
Residual (peak and mean) transvalvular gradient
Effective orifice area (EOA)
Time frame: 1-3 months
EOA evaluated by echocardiography imaging
Prosthesis-patient mismatch
Time frame: 1-3 months
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).
Paravalvular leaks
Time frame: 1-3 months
Paravalvular leaks evaluated by echocardiography imaging

10 secondary outcomes

Transvalvular gradient
Time frame: 1-, 3-5-, 6-8-, and 9-10-year follow-up.
Effective orifice area (EOA)
Time frame: 1-, 3-5-, 6-8-, and 9-10-year follow-up.
Bioprosthetic valve dysfunction
Time frame: 1-, 3-5-, 6-8-, and 9-10-year follow-up.
Paravalvular leaks
Time frame: 1-, 3-5-, 6-8-, and 9-10-year follow-up.
Bioprosthetic valve dysfunction
Time frame: yearly
Bioprosthetic valve failure
Time frame: yearly
Bioprosthetic valve failure
Time frame: 1-, 3-5-, 6-8-, and 9-10-year follow-up.
Clinical events
Time frame: 1month and yearly up to 10-year
Valve thrombosis
Time frame: 1-3 months and yearly up to 10-year
Valve endocarditis
Time frame: 1-3 months and yearly up to 10-year

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Background: PubMed 33972115Writing 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.
Background: PubMed 34453165Vahanian 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.
Background: PubMed 30883058Mack 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.
Background: PubMed 30883053Popma 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.
Background: PubMed 37229228Montarello 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.
Background: PubMed 32278660Ferreira-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.
Background: PubMed 20961243Leon 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Josep Rodés-Cabau, MD contact

4186568711

josep.rodes@criucpq.ulaval.ca

Emilie Pelletier beaumont, MSc contact

418-656-8711 ext. 3929

emilie.pelletier-beaumont@criucpq.ulaval.ca

Josep Rodés-Cabau, MD principal investigator

IUCPQ-UL

Emilie Pelletier beaumont, MSc study director

Fondation IUCPQ

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Josep Rodés-Cabau, MD (4186568711, josep.rodes@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transvalvular gradient (time frame: 1-3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06420830, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.