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PARTNER 3 Trial - Mitral Valve in Valve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03193801
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : February 5, 2020
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing mitral bioprosthetic valve.

Condition or disease Intervention/treatment Phase
Mitral Valve Insufficiency Mitral Valve Disease Mitral Valve Regurgitation Heart Failure Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX Not Applicable

Detailed Description:
A prospective, single-arm, multicenter clinical trial. This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed, insufficient, or combined).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PARTNER 3 Trial - Mitral Valve in Valve is a Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2024

Arm Intervention/treatment
Experimental: Failing mitral transcatheter valve
Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.
Other Name: TMVR

Primary Outcome Measures :
  1. Safety and Effectiveness - composite endpoint of all-cause mortality and stroke [ Time Frame: 1 Year ]
    Non-hierarchical composite endpoint of all-cause mortality and stroke at 1 year post procedure.

Secondary Outcome Measures :
  1. New York Heart Association (NYHA) Functional Class [ Time Frame: 30 Days ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
  2. NYHA Functional Class ≥ II.
  3. Heart Team agrees that the patient is at intermediate surgical risk.
  4. Heart Team agrees valve implantation will likely benefit the patient.
  5. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

Exclusion Criteria:

  1. Index valve has ≥ mild paravalvular regurgitation where the surgical bioprosthesis is not securely fixed in the native annulus or is not structurally intact as determined by transesophageal echocardiography (TEE).
  2. Aortomitral angle <105°.
  3. Severe regurgitation or stenosis of any other valve.
  4. Severe right ventricle (RV) dysfunction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03193801

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Contact: Sharanjeet Dhanjal 949-250-2083
Contact: John Tejeda, MD 949-250-8497

Show Show 17 study locations
Sponsors and Collaborators
Edwards Lifesciences
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Principal Investigator: Mayra Guerrero, MD Mayo Clinic
Principal Investigator: Chris S. Malaisrie, MD Northwestern University Feinberg School of Medicine
Principal Investigator: Alan Zajarias, MD Washington University School of Medicine

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Responsible Party: Edwards Lifesciences Identifier: NCT03193801    
Other Study ID Numbers: 2015-08 MVIV
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Edwards Lifesciences:
cardiovascular disease
failing valve
failing bioprosthetic valve
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases