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ClinicalTrials.gov public records Last synced Sep 13, 2026, 3:14 PM EDT

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Showing 1–21 of 21 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: SAPIEN Transcatheter Valve Implantation Clear all
Completed Not applicable Interventional Results available

COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV

NCT00676689
View directory record Official record
Conditions
Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction, Pulmonary Stenosis
Interventions
SAPIEN Transcatheter Valve Implantation
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
Not listed
Enrollment
81 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2019
U.S. locations
7
States / cities
Los Angeles, California • Miami, Florida • Atlanta, Georgia + 4 more
Source: ClinicalTrials.gov public record
Updated Feb 25, 2020 · Synced Sep 13, 2026, 3:14 PM EDT
Completed Not applicable Interventional Results available

The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B

NCT02184442
View directory record Official record
Conditions
Severe, Symptomatic, Calcific Aortic Stenosis
Interventions
TAVR Implantation with SAPIEN XT, TAVR Implantation with SAPIEN
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
19 Years and older
Enrollment
560 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2017
U.S. locations
53
States / cities
Little Rock, Arkansas • La Jolla, California • Los Angeles, California + 45 more
Source: ClinicalTrials.gov public record
Updated Sep 24, 2018 · Synced Sep 13, 2026, 3:14 PM EDT
Recruiting Not applicable Interventional

The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).

NCT04408430
View directory record Official record
Conditions
Mitral Annular Calcification, Mitral Stenosis, Mitral Regurgitation, Mitral Valve Disease
Interventions
Transseptal ViMAC
Device
Lead sponsor
Mayra Guerrero
Other
Eligibility
18 Years and older
Enrollment
210 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2030
U.S. locations
16
States / cities
Gilbert, Arizona • Phoenix, Arizona • Tucson, Arizona + 12 more
Source: ClinicalTrials.gov public record
Updated Jan 12, 2026 · Synced Sep 13, 2026, 3:14 PM 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 13, 2026, 3:14 PM EDT
Completed No phase listed Observational

COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction

NCT02987387
View directory record Official record
Conditions
Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities, Cardiovascular Diseases, Heart Diseases
Interventions
SAPIEN XT THV
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
Not listed
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2025
U.S. locations
12
States / cities
Birmingham, Alabama • Aurora, Colorado • Washington D.C., District of Columbia + 9 more
Source: ClinicalTrials.gov public record
Updated Dec 14, 2025 · Synced Sep 13, 2026, 3:14 PM 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 13, 2026, 3:14 PM EDT
Completed Not applicable Interventional Results available

Transcatheter Valve Implantation in Patients With Dysfunctional Left and Right Sided Heart Valves

NCT02119442
View directory record Official record
Conditions
Eisenmenger Syndrome
Interventions
Transcather Valve Implantation
Device
Lead sponsor
University of California, Los Angeles
Other
Eligibility
Not listed
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2018
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Apr 29, 2019 · Synced Sep 13, 2026, 3:14 PM EDT
Recruiting Not applicable Interventional

ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

NCT05172973
View directory record Official record
Conditions
Aortic Valve Insufficiency, Aortic Valve Stenosis
Interventions
SAPIEN X4/X4S THV
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
Not listed
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2039
U.S. locations
33
States / cities
Newport Beach, California • San Francisco, California • Stanford, California + 25 more
Source: ClinicalTrials.gov public record
Updated Jul 26, 2026 · Synced Sep 13, 2026, 3:14 PM 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 13, 2026, 3:14 PM 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 13, 2026, 3:14 PM EDT
Completed Phase 3 Interventional Results available

Heterotopic Implantation Of the Edwards-Sapien Transcatheter Aortic Valve in the Inferior VEna Cava for the Treatment of Severe Tricuspid Regurgitation (HOVER)

NCT02339974
View directory record Official record
Conditions
Tricuspid Regurgitation
Interventions
Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna Cava
Device
Lead sponsor
Henry Ford Health System
Other
Eligibility
22 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2025
U.S. locations
1
States / cities
Detroit, Michigan
Source: ClinicalTrials.gov public record
Updated Jun 17, 2025 · Synced Sep 13, 2026, 3:14 PM EDT
Completed Not applicable Interventional Results available

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk

NCT01314313
View directory record Official record
Conditions
Symptomatic Severe Aortic Stenosis
Interventions
TAVR Implantation with SAPIEN XT, SAVR Implantation
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
Not listed
Enrollment
2,032 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2024
U.S. locations
55
States / cities
Little Rock, Arkansas • La Jolla, California • Los Angeles, California + 46 more
Source: ClinicalTrials.gov public record
Updated Mar 6, 2024 · Synced Sep 13, 2026, 3:14 PM EDT
Withdrawn Not applicable Interventional

Supra-Annular vs. Annular ValvEs for Small Annuli

NCT04372381
View directory record Official record
Conditions
Aortic Valve Stenosis, Implantation, Heart Valve Prosthesis
Interventions
Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
Device
Lead sponsor
University of Arizona
Other
Eligibility
Not listed
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
3
States / cities
Phoenix, Arizona • Tucson, Arizona • Delray Beach, Florida
Source: ClinicalTrials.gov public record
Updated Jul 23, 2026 · Synced Sep 13, 2026, 3:14 PM EDT
Recruiting Not applicable Interventional

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

NCT05172960
View directory record Official record
Conditions
Aortic Stenosis, Severe
Interventions
SAPIEN X4 THV, SAPIEN X4S
Device
Lead sponsor
Edwards Lifesciences
Industry
Eligibility
Not listed
Enrollment
1,234 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2037
U.S. locations
58
States / cities
La Jolla, California • Los Angeles, California • Newport Beach, California + 44 more
Source: ClinicalTrials.gov public record
Updated Sep 2, 2026 · Synced Sep 13, 2026, 3:14 PM 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 13, 2026, 3:14 PM 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 13, 2026, 3:14 PM 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 13, 2026, 3:14 PM EDT
Completed Not applicable Interventional Results available

Mitral Implantation of TRAnscatheter vaLves

NCT02370511
View directory record Official record
Conditions
Mitral Valve Disease
Interventions
Transcatheter Mitral Valve Replacement
Device
Lead sponsor
Mayra Guerrero
Other
Eligibility
22 Years and older
Enrollment
91 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
15
States / cities
Phoenix, Arizona • Los Angeles, California • Washington D.C., District of Columbia + 9 more
Source: ClinicalTrials.gov public record
Updated Oct 9, 2023 · Synced Sep 13, 2026, 3:14 PM EDT
Active, not recruiting Not applicable Interventional Results available

ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement

NCT03735667
View directory record Official record
Conditions
Aortic Stenosis
Interventions
ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System, ACURATE Prime™ Transfemoral TAVR System XL
Device
Lead sponsor
Boston Scientific Corporation
Industry
Eligibility
Not listed
Enrollment
1,948 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2029
U.S. locations
69
States / cities
Birmingham, Alabama • Phoenix, Arizona • Scottsdale, Arizona + 58 more
Source: ClinicalTrials.gov public record
Updated May 3, 2026 · Synced Sep 13, 2026, 3:14 PM 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 13, 2026, 3:14 PM EDT
Completed Not applicable Interventional Results available

NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation

NCT03015194
View directory record Official record
Conditions
Mitral Valve Failure
Interventions
Edwards SAPIEN 3 transcatheter heart valve, ASHI INTECC Astato XS 20
Device
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Eligibility
21 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2023
U.S. locations
6
States / cities
Washington D.C., District of Columbia • Atlanta, Georgia • Detroit, Michigan + 3 more
Source: ClinicalTrials.gov public record
Updated Aug 14, 2023 · Synced Sep 13, 2026, 3:14 PM EDT