PARTNER 3 Trial - Aortic Valve-in-Valve

May 8, 2024 updated by: Edwards Lifesciences

A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, single-arm, multicenter study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Recruiting
        • St. Paul's Hospital, Providence Health Care
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner University Medical Center
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles
      • Sacramento, California, United States, 95919
        • Recruiting
        • Sutter Medical Center
      • San Francisco, California, United States, 94115
        • Withdrawn
        • Kaiser Permanente San Francisco
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University Medical Center
    • Colorado
      • Loveland, Colorado, United States, 80538
        • Recruiting
        • UC Health Northern Colorado/Medical Center of the Rockies
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
    • Florida
      • Atlantis, Florida, United States, 33462
        • Withdrawn
        • JFK Medical Center/ Atlantic Clinical Research Collaborative
      • Gainesville, Florida, United States, 32610
        • Withdrawn
        • University of Florida, Gainesville
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University Hospital
      • Evanston, Illinois, United States, 60201
        • Withdrawn
        • Northshore University Healthsystem
      • Springfield, Illinois, United States, 62701
        • Withdrawn
        • Prairie Education and Research Cooperative
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
      • Royal Oak, Michigan, United States, 48073
        • Withdrawn
        • William Beaumont Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Withdrawn
        • University of Minnesota Medical Center
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Withdrawn
        • Saint Luke's Hospital of Kansas City Mid America
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University/ Barnes-Jewish Hospital
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Withdrawn
        • Nebraska Heart Institute
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Withdrawn
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Recruiting
        • Newark Beth Israel
    • New York
      • Buffalo, New York, United States, 14203
        • Withdrawn
        • University of Buffalo
      • Mineola, New York, United States, 11501
        • Recruiting
        • Winthrop University Hospital
      • New York, New York, United States, 10021
        • Recruiting
        • Cornell University
      • New York, New York, United States, 10016
        • Withdrawn
        • New York University (NYU) Langone Medical Center
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center/ New York Presbyterian Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Withdrawn
        • Carolina's Health System
      • Raleigh, North Carolina, United States, 27607
        • Withdrawn
        • NC Heart and Vascular (Rex Hospital)
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Christ Hospital
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • The Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Withdrawn
        • Oklahoma Cardiovascular Research Group
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Heart & Vascular Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Withdrawn
        • Baptist Memorial Hospital
      • Nashville, Tennessee, United States, 37205
        • Withdrawn
        • Saint Thomas Health Services
    • Texas
      • Austin, Texas, United States, 78756
        • Withdrawn
        • Austin Heart, PLLC
      • Dallas, Texas, United States, 75093
        • Recruiting
        • Medical City Dallas Hospital
      • Dallas, Texas, United States, 75093
        • Recruiting
        • The Heart Hospital Baylor Plano
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
    • Utah
      • Murray, Utah, United States, 84157
        • Recruiting
        • Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Withdrawn
        • University of Virginia
      • Fairfax, Virginia, United States, 22042
        • Withdrawn
        • Inova Heart and vascular Instritute (Fairfax Inova)
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Cardiovascular Research Institute
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Withdrawn
        • University of Wisconsin - Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
  2. Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
  3. NYHA Functional Class ≥ II.
  4. Heart Team agrees the patient is low to intermediate risk.
  5. Heart Team agrees valve implantation will likely benefit the patient.
  6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

  1. Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)
  2. Severe regurgitation (> 3+) or stenosis of any other valve
  3. Failing valve has moderate or severe paravalvular regurgitation
  4. Failing valve is unstable, rocking, or not structurally intact
  5. Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
  6. Increased risk of embolization of THV
  7. Known bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve
  8. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)
  9. Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
  10. Anatomical characteristics that would preclude safe access to the apex (Transapical)
  11. Evidence of an acute myocardial infarction ≤ 30 days before enrollment
  12. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.
  13. Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation
  14. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
  15. Untreated clinically significant coronary artery disease requiring revascularization
  16. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment
  17. Emergency interventional/surgical procedures within 30 days prior to the procedure
  18. Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure
  19. Hypertrophic cardiomyopathy with obstruction
  20. LVEF < 30%
  21. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
  22. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
  23. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
  24. Stroke or transient ischemic attack within 90 days of enrollment
  25. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
  26. Renal insufficiency and/or renal replacement therapy at the time of screening
  27. Active bacterial endocarditis within 180 days of the procedure
  28. Patient refuses blood products
  29. Estimated life expectancy < 24 months
  30. Positive urine or serum pregnancy test in female subjects of childbearing potential
  31. Currently participating in an investigational drug or another device study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TAVR - Failing surgical or transcatheter valve
Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).
Device: Edwards SAPIEN 3/SAPIEN 3 Ultra THV
Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke
Time Frame: 1 year
Number of patients that died and/or had a stroke
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean gradient
Time Frame: 30 days
Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.
30 days
Peak gradient
Time Frame: 30 days
Measures the peak aortic pressure gradient from the measured velocity. Units used are mmHg.
30 days
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 30 days
Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life.
30 days
New York Heart Association (NYHA) Classification
Time Frame: 30 days
Change from baseline in NYHA. NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
30 days
Six-Minute Walk Test (6MWT)
Time Frame: 30 days
Change from baseline in 6MWT. The 6-Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Edwards Lifesciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mayra Guerrero, MD, Mayo Clinic
  • Principal Investigator: Alan Zajarias, MD, Washington University School of Medicine
  • Principal Investigator: Chris S Malaisrie, MD, Northwestern University Feinberg School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2033

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2038

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015-08 AVIV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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