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Aortic StenosisP3NCT02675114

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

A study testing SAVR and SAPIEN 3 THV in people with Aortic Stenosis, run by Edwards Lifesciences at 77 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement. Read more about this study

Who is it for?
Any age
Conditions the study is for
Aortic Stenosis
What is being tested?
SAVR and SAPIEN 3 THV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
77 sitesin 5 countries
Study dates
Mar 2016to Dec 2029
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Severe, calcific aortic stenosis
  • New York Heart Association Functional Class ≥ 2 OR exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR asymptomatic with Left Ventricular Ejection Fraction (LVEF) <50%
  • Heart team agrees the patient has a risk of operative mortality and has an Society of Thoracic Surgeons (STS) score < 4
  • The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Who cannot join

  • Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm transcatheter heart valve
  • Iliofemoral vessel characteristics that would preclude safe passage of the introducer sheath
  • Evidence of an acute myocardial infarction ≤ 30 days before randomization
  • Aortic valve is unicuspid, bicuspid, or non-calcified
  • Severe aortic regurgitation (>3+)
  • Severe mitral regurgitation (>3+) ≥ moderate stenosis
Show all 34Show fewer
  • Pre-existing mechanical or bioprosthetic valve in any position
  • Complex coronary artery disease:
  • Unprotected left main coronary artery
  • Syntax score > 32
  • Heart Team assessment that optimal revascularization cannot be performed
  • Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization
  • Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
  • Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization
  • Hypertrophic cardiomyopathy with obstruction
  • Ventricular dysfunction with LVEF < 30%
  • Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
  • Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
  • Stroke or transient ischemic attack within 90 days of randomization
  • Renal insufficiency and/or renal replacement therapy at the time of screening.
  • Active bacterial endocarditis within 180 days of randomization
  • Severe lung disease or currently on home oxygen
  • Severe pulmonary hypertension
  • History of cirrhosis or any active liver disease
  • Significant frailty as determined by the Heart Team
  • Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system or cannulation and aortotomy for surgical aortic valve replacement
  • Hostile chest or conditions or complications from prior surgery that would preclude safe reoperation
  • Patient refuses blood products
  • Body mass index > 50 kg/m2
  • Estimated life expectancy < 24 months
  • Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
  • Immobility that would prevent completion of study procedures
  • Patient is not a candidate for both arms of the study
  • Currently participating in an investigational drug or another device study.

Trial locations and contacts

77 sites in 5 countries.

77 sites in 5 countries

United States68 sites

  • Albany

    Albany, New York, 12208

  • Emory University

    Atlanta, Georgia, 30322

  • JFK Medical Center / Atlantic Clinical Research Collaborative

    Atlantis, Florida, 33462

  • Central Maine Medical Center

    Auburn, Maine, 04210

  • Austin Heart

    Austin, Texas, 78756

  • University of Alabama

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • University of Buffalo

    Buffalo, New York, 14203

  • Mills/Peninsula Health Services

    Burlingame, California, 94010

  • Carolina's Health System

    Charlotte, North Carolina, 28203

  • UPR - Novant Health Heart and Vascular Institution

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22904

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The Christ Hospital, Cincinnati

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Mount Carmel Health System

    Columbus, Ohio, 43213

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • NorthShore University HealthSystem Research Institute

    Evanston, Illinois, 60201

  • Fairfax INOVA

    Falls Church, Virginia, 22042

  • University of Florida, Gainesville

    Gainesville, Florida, 32610

  • Hartford

    Hartford, Connecticut, 06102

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Saint Luke's Hospital of Kansas City Mid America

    Kansas City, Missouri, 64111

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of California, Los Angeles/Ronald Reagan Medical Center

    Los Angeles, California, 90095

  • UC Health Northern Colorado/Medical Center of the Rockies

    Loveland, Colorado, 80538

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Winthrop-University Hospital

    Mineola, New York, 11501

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

  • Morristown Medical Center / Atlantic Health System Hospital

    Morristown, New Jersey, 07962

  • Saint Thomas Health Services

    Nashville, Tennessee, 37205

  • UPR - Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • NYU Medical Center

    New York, New York, 10016

  • Cornell University

    New York, New York, 10021

  • Columbia University Medical Center/ New York Presbyterian Hospital

    New York, New York, 10032

  • Newark Beth Israel

    Newark, New Jersey, 07112

  • Hoag Hospital

    Newport Beach, California, 92663

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23507

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, Oklahoma, 73120

  • Florida Hospital

    Orlando, Florida, 32803

  • Stanford Hospital and Clinics

    Palo Alto, California, 94305

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Banner University Medical Center

    Phoenix, Arizona, 85006

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • The Heart Hosptial Baylor Plano

    Plano, Texas, 75093

  • Providence Heart & Vascular Institute

    Portland, Oregon, 97225

  • Rex Hospital / NC Heart and Vascular Research

    Raleigh, North Carolina, 27607

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Sutter Health Sacramento

    Sacramento, California, 95816

  • Intermountain Medical Center

    Salt Lake City, Utah, 84157

  • Kaiser Permanente San Francisco

    San Francisco, California, 94115

  • University of Washington

    Seattle, Washington, 98195

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62701

  • Barnes-Jewish Hospital / Washington University

    St Louis, Missouri, 63110

  • UPR-Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 67226

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • York Hospital

    York, Pennsylvania, 17403

Other trials in United States

Japan5 sites

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873

  • Keio University

    Shinjuku, Tokyo, 160-8582

  • Osaka University

    Suita, Osaka, 565-0871

  • Teikyo University

    tabashi City, Tokyo, 173-8606

Other trials in Japan

Australia2 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

Other trials in Australia

Canada1 site

  • Saint Paul's Hospital

    Vancouver

Other trials in Canada

New Zealand1 site

  • Auckland City Hospital

    Grafton, Auckland, 1024

Other trials in New Zealand

About this study

Official title: A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.

Read the detailed description

Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 10 years.

A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/Quality of Life. Additional patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations Registry (UPR) or the Alternative Access Registry.

Conditions
Aortic Stenosis
Being tested
SAVR, SAPIEN 3 THV
Keywords
SAPIEN 3, cardiovascular disease, heart disease, aortic stenosis, Surgical aortic valve replacement (SAVR), Transcatheter aortic valve replacement (TAVR)
Medical subject headings
Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases

What participants receive

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

  • SAVRProcedure or surgery

    SAVR with a commercially available bioprosthetic valve.

  • SAPIEN 3 THVDevice

    TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System

Study groups in NCT02675114
Study groupRoleWhat they receive
Surgical aortic valve replacement (SAVR)Active comparatorNot described
Receives: Procedure: SAVR
Transcatheter aortic valve replacement (TAVR)ExperimentalNot described
Receives: Device: SAPIEN 3 THV

What is being measured

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

  1. All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure)

    Number of patients that had any of these events

    Measured: 1 year

Secondary outcomes (5)

  1. New Onset Atrial Fibrillation

    Number of patients with this event

    Measured: 30 days

  2. Length of Index Hospitalization

    Number of days from index procedure to discharge

    Measured: Discharge (expected average of 7 days)

  3. Death, Kansas City Cardiomyopathy Questionnaire (KCCQ) Score < 45 or KCCQ Score Decrease ≥ 10 Points

    Number of patients that had any of these events

    Measured: 30 days

  4. Death or Stroke

    Number of patients that died or had a stroke

    Measured: 30 days

  5. All Stroke

    Number of patients that had a stroke

    Measured: 30 days

Timeline

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

  1. First posted5 Feb 2016 (estimated)
  2. Study startMar 2016
  3. Primary completion16 Nov 2020
  4. Study completionDec 2029 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02675114
Sponsor's protocol ID
2015-08
Acronym
P3
Status last verified
Dec 2025
First submitted
22 Jan 2016
Last updated
14 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Brener MI, Cohen DJ, Kodali SK, Hahn RT, Thourani VH, Makkar RR, Pibarot P, Yu X, Lubich B, Mack MJ, Leon MB, Arnold SV. Health Status Outcomes 7 Years After Transcatheter or Surgical Aortic Valve Replacement in Low-Surgical Risk Patients With Aortic Stenosis. J Am Coll Cardiol. 2026 Jul 17:S0735-1097(26)06898-1. doi: 10.1016/j.jacc.2026.06.022. Online ahead of print.

    PubMed 42524810

  • Madhavan MV, Mack MJ, Pibarot P, Hahn RT, Makkar R, Thourani VH, Kodali SK, Kapadia SR, Genereux P, Babaliaros V, Alu MC, Lubich B, Leon MB, Cohen DJ; PARTNER 3 Investigators. Impact of Aortic Annulus Size on Outcomes After Aortic Valve Replacement: The PARTNER 3 Trial. JACC Cardiovasc Interv. 2026 Jul 27;19(14):1944-1955. doi: 10.1016/j.jcin.2026.05.023.

    PubMed 42508852

  • Ternacle J, Hahn RT, Silva I, Alperi A, Giuliani C, Zanuttini A, Theron A, Dahou A, Cristell N, Woods T, Guzzetti E, Turgeon PY, Bernier M, Mahjoub H, Paquin A, Skaf S, Beaudoin J, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Leipsic J, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Nazif TM, Zhang Y, Gunnarsson M, Webb JG, Makkar RR, Thourani VH, Mack MJ, Leon MB, Pibarot P; PARTNER 3 Investigators. Seven-Year Valve Durability With Transcatheter or Surgical Aortic Valve Replacement: An Ad Hoc Analysis of the PARTNER 3 Randomized Clinical Trial. JAMA Cardiol. 2026 Aug 1;11(8):747-757. doi: 10.1001/jamacardio.2026.2299.

    PubMed 42340728

  • Leon MB, Mack MJ, Pibarot P, Hahn RT, Thourani VH, Kodali SH, Genereux P, Kapadia SR, Cohen DJ, Pocock SJ, Zhang Y, Szerlip M, Ternacle J, Malaisrie SC, Herrmann HC, Szeto WY, Russo MJ, Babaliaros V, Nazif T, Webb JG, Makkar RR; PARTNER 3 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years. N Engl J Med. 2026 Feb 19;394(8):773-783. doi: 10.1056/NEJMoa2509766. Epub 2025 Oct 27.

    PubMed 41144631

  • Hahn RT, Ternacle J, Silva I, Giuliani C, Zanuttini A, Theron A, Cristell N, Bernier M, Skaf S, Beaudoin J, Kodali SK, Russo M, Kapadia SR, Malaisrie CS, Cohen DJ, Leipsic J, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Park B, Gunnarsson M, Webb JG, Smith CR, Makkar R, Thourani VH, Mack MJ, Leon MB, Pibarot P; PARTNER 3 Investigators. 5-Year Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients. JACC Cardiovasc Imaging. 2025 Jun;18(6):625-640. doi: 10.1016/j.jcmg.2025.01.015. Epub 2025 Apr 16.

    PubMed 40243974

  • Mack MJ, Leon MB, Thourani VH, Pibarot P, Hahn RT, Genereux P, Kodali SK, Kapadia SR, Cohen DJ, Pocock SJ, Lu M, White R, Szerlip M, Ternacle J, Malaisrie SC, Herrmann HC, Szeto WY, Russo MJ, Babaliaros V, Smith CR, Blanke P, Webb JG, Makkar R; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years. N Engl J Med. 2023 Nov 23;389(21):1949-1960. doi: 10.1056/NEJMoa2307447. Epub 2023 Oct 24.

    PubMed 37874020

  • Genereux P, Cohen DJ, Pibarot P, Redfors B, Bax JJ, Zhao Y, Prince H, Makkar RR, Kapadia S, Thourani VH, Mack MJ, Nazif TM, Lindman BR, Babaliaros V, Russo M, McCabe JM, Gillam LD, Alu MC, Hahn RT, Webb JG, Leon MB, Arnold SV. Cardiac Damage and Quality of Life After Aortic Valve Replacement in the PARTNER Trials. J Am Coll Cardiol. 2023 Feb 28;81(8):743-752. doi: 10.1016/j.jacc.2022.11.059.

    PubMed 36813373

  • Kuck KH, Leidl R, Frankenstein L, Wahlers T, Sarmah A, Candolfi P, Shore J, Green M. Cost-Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in German Severe Aortic Stenosis Patients at Low Surgical Mortality Risk. Adv Ther. 2023 Mar;40(3):1031-1046. doi: 10.1007/s12325-022-02392-y. Epub 2023 Jan 9.

    PubMed 36622552

  • Genereux P, Pibarot P, Redfors B, Bax JJ, Zhao Y, Makkar RR, Kapadia S, Thourani VH, Mack MJ, Nazif TM, Lindman BR, Babaliaros V, Vincent F, Russo M, McCabe JM, Gillam LD, Alu MC, Hahn RT, Webb JG, Leon MB, Cohen DJ. Evolution and Prognostic Impact of Cardiac Damage After Aortic Valve Replacement. J Am Coll Cardiol. 2022 Aug 23;80(8):783-800. doi: 10.1016/j.jacc.2022.05.006. Epub 2022 May 17.

    PubMed 35595203

  • Ternacle J, Al-Azizi K, Szerlip M, Potluri S, Hamandi M, Blanke P, Leipsic J, Dahou A, Salaun E, Vincent F, Rogers E, Alu MC, Lu M, Yu X, Thourani VH, Hahn RT, Leon MB, Pibarot P, Mack MJ. Impact of Predilation During Transcatheter Aortic Valve Replacement: Insights From the PARTNER 3 Trial. Circ Cardiovasc Interv. 2021 Jul;14(7):e010336. doi: 10.1161/CIRCINTERVENTIONS.120.010336. Epub 2021 Jun 18.

    PubMed 34139864

  • Herrmann HC, Cohen DJ, Hahn RT, Babaliaros VC, Yu X, Makkar R, McCabe J, Szerlip M, Kapadia S, Russo M, Malaisrie SC, Webb JG, Szeto WY, Kodali S, Thourani VH, Mack MJ, Leon MB. Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2021 Jul;14(7):e010310. doi: 10.1161/CIRCINTERVENTIONS.120.010310. Epub 2021 Jun 16.

    PubMed 34130476

  • Leon MB, Mack MJ, Hahn RT, Thourani VH, Makkar R, Kodali SK, Alu MC, Madhavan MV, Chau KH, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Blanke P, Leipsic JA, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Herrmann HC, Szeto WY, Genereux P, Pershad A, Lu M, Webb JG, Smith CR, Pibarot P; PARTNER 3 Investigators. Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk. J Am Coll Cardiol. 2021 Mar 9;77(9):1149-1161. doi: 10.1016/j.jacc.2020.12.052.

    PubMed 33663731

  • Pibarot P, Salaun E, Dahou A, Avenatti E, Guzzetti E, Annabi MS, Toubal O, Bernier M, Beaudoin J, Ong G, Ternacle J, Krapf L, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Leipsic J, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Alu MC, Xu K, Rogers E, Webb JG, Smith CR, Mack MJ, Leon MB, Hahn RT; PARTNER 3 Investigators. Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial. Circulation. 2020 May 12;141(19):1527-1537. doi: 10.1161/CIRCULATIONAHA.119.044574. Epub 2020 Apr 10.

    PubMed 32272848

  • 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

  • Leipsic J, Bax JJ, Webb JG, Martin R, Blanke P. Trials Testing the Value of Imaging Use in Valve Disease and in Transcatheter Valvular Interventions. JACC Cardiovasc Imaging. 2017 Mar;10(3):286-295. doi: 10.1016/j.jcmg.2016.09.031.

    PubMed 28279376

Questions about this trial

What is this clinical trial studying?

A study testing SAVR and SAPIEN 3 THV in people with Aortic Stenosis, run by Edwards Lifesciences at 77 sites in 5 countries.

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 4 inclusion and 34 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: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Japan, Australia, Canada, New Zealand. 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?

Yes. Results are posted in the registry (first posted 2 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure) (time frame: 1 year). 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 NCT02675114, which also lists 15 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 14 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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