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ClinicalTrials.gov public records Last synced Sep 3, 2026, 3:16 AM EDT

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Showing 1–14 of 14 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Filters: Intervention: SAPIEN 3 THV Clear all
Active, not recruiting Not applicable Interventional Results available

SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

NCT04722250
View directory record Official record
Conditions
Symptomatic Aortic Stenosis, Aortic Valve Stenosis, Aortic Valve Replacement
Interventions
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems, Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
Device
Lead sponsor
Medtronic Cardiovascular
Industry
Eligibility
18 Years and older
Enrollment
1,103 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
61
States / cities
La Jolla, California • Los Angeles, California • San Francisco, California + 47 more
Source: ClinicalTrials.gov public record
Updated Jun 1, 2026 · Synced Sep 3, 2026, 3:16 AM EDT
Active, not recruiting Not applicable Interventional Results available

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

NCT03130777
View directory record Official record
Conditions
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease, Pulmonary Regurgitation
Interventions
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
Not listed
Enrollment
86 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2032
U.S. locations
14
States / cities
Los Angeles, California • San Francisco, California • Aurora, Colorado + 10 more
Source: ClinicalTrials.gov public record
Updated Sep 24, 2025 · Synced Sep 3, 2026, 3:16 AM EDT
Completed Not applicable Interventional Results available

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7

NCT03222141
View directory record Official record
Conditions
Symptomatic Severe Aortic Stenosis
Interventions
TAVR Implantation of the THV Prosthesis
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
19 Years and older
Enrollment
583 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2020
U.S. locations
39
States / cities
Los Angeles, California • Sacramento, California • Stanford, California + 34 more
Source: ClinicalTrials.gov public record
Updated May 11, 2021 · Synced Sep 3, 2026, 3:16 AM EDT
Active, not recruiting No phase listed Observational

ALTERRA Post-Approval Study

NCT05378386
View directory record Official record
Conditions
Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation, RVOT Anomaly
Interventions
Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
Not listed
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2035
U.S. locations
23
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Los Angeles, California + 18 more
Source: ClinicalTrials.gov public record
Updated Nov 3, 2025 · Synced Sep 3, 2026, 3:16 AM EDT
Completed Not applicable Interventional Results available

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve

NCT03225001
View directory record Official record
Conditions
Aortic Stenosis, Cardiomyopathy, Hypertrophic
Interventions
Edwards SAPIEN XT transcatheter valve, Model 9300TFX
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
Not listed
Enrollment
197 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2020
U.S. locations
46
States / cities
La Jolla, California • Los Angeles, California • Sacramento, California + 39 more
Source: ClinicalTrials.gov public record
Updated Mar 8, 2021 · Synced Sep 3, 2026, 3:16 AM EDT
Recruiting Not applicable Interventional

PARTNER 3 Trial - Aortic Valve-in-Valve

NCT03003299
View directory record Official record
Conditions
Aortic Stenosis, Aortic Stenosis, Severe
Interventions
Edwards SAPIEN 3/SAPIEN 3 Ultra THV
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
Not listed
Enrollment
125 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2038
U.S. locations
50
States / cities
Phoenix, Arizona • Los Angeles, California • Sacramento, California + 43 more
Source: ClinicalTrials.gov public record
Updated May 9, 2024 · Synced Sep 3, 2026, 3:16 AM EDT
Completed Not applicable Interventional Results available

PARTNER II Trial: S3iCAP

NCT02687035
View directory record Official record
Conditions
Aortic Stenosis
Interventions
SAPIEN S3 valve
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
Not listed
Enrollment
1,822 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
55
States / cities
La Jolla, California • Los Angeles, California • Palo Alto, California + 46 more
Source: ClinicalTrials.gov public record
Updated Apr 7, 2021 · Synced Sep 3, 2026, 3:16 AM EDT
Active, not recruiting No phase listed Observational

COMPASSION S3 Post-Approval Study

NCT04860765
View directory record Official record
Conditions
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Pulmonary Valve; Obstruction
Interventions
SAPIEN 3 THV
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
Not listed
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2030
U.S. locations
19
States / cities
Birmingham, Alabama • Los Angeles, California • Aurora, Colorado + 15 more
Source: ClinicalTrials.gov public record
Updated Feb 2, 2026 · Synced Sep 3, 2026, 3:16 AM EDT
Active, not recruiting Not applicable Interventional Results available

PARTNER 3 Trial - Mitral Valve in Valve

NCT03193801
View directory record Official record
Conditions
Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure
Interventions
Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
Not listed
Enrollment
53 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2031
U.S. locations
9
States / cities
Atlanta, Georgia • Chicago, Illinois • Evanston, Illinois + 6 more
Source: ClinicalTrials.gov public record
Updated Nov 4, 2025 · Synced Sep 3, 2026, 3:16 AM EDT
Active, not recruiting Not applicable Interventional

Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)

NCT02661451
View directory record Official record
Conditions
Aortic Valve Stenosis
Interventions
SAPIEN 3 THV, Optimal Heart Failure Therapy
Device · Biological
Lead sponsor
Cardiovascular Research Foundation, New York
Other
Eligibility
18 Years and older
Enrollment
178 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2025
U.S. locations
46
States / cities
Chandler, Arizona • La Jolla, California • Los Angeles, California + 37 more
Source: ClinicalTrials.gov public record
Updated Nov 26, 2024 · Synced Sep 3, 2026, 3:16 AM EDT
Completed Not applicable Interventional Results available

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate

NCT03222128
View directory record Official record
Conditions
Symptomatic Severe Aortic Stenosis
Interventions
TAVR
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
19 Years and older
Enrollment
1,074 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2024
U.S. locations
51
States / cities
La Jolla, California • Los Angeles, California • Sacramento, California + 44 more
Source: ClinicalTrials.gov public record
Updated Jan 2, 2025 · Synced Sep 3, 2026, 3:16 AM EDT
Recruiting Not applicable Interventional

COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

NCT02744677
View directory record Official record
Conditions
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
Interventions
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
Not listed
Enrollment
108 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2031
U.S. locations
27
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Los Angeles, California + 20 more
Source: ClinicalTrials.gov public record
Updated Jul 22, 2026 · Synced Sep 3, 2026, 3:16 AM EDT
Active, not recruiting Not applicable Interventional Results available

PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

NCT02675114
View directory record Official record
Conditions
Aortic Stenosis
Interventions
SAVR, SAPIEN 3 THV
Procedure · Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
Not listed
Enrollment
1,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2029
U.S. locations
68
States / cities
Birmingham, Alabama • Phoenix, Arizona • Burlingame, California + 59 more
Source: ClinicalTrials.gov public record
Updated Jan 13, 2026 · Synced Sep 3, 2026, 3:16 AM EDT
Active, not recruiting Not applicable Interventional

EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

NCT03042104
View directory record Official record
Conditions
Heart Diseases, Aortic Stenosis, Severe
Interventions
Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
65 Years and older
Enrollment
901 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2032
U.S. locations
74
States / cities
Phoenix, Arizona • Burlingame, California • Los Angeles, California + 62 more
Source: ClinicalTrials.gov public record
Updated May 12, 2024 · Synced Sep 3, 2026, 3:16 AM EDT