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Trial record 24 of 217 for:    heart disease AND stroke AND California

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.
ClinicalTrials.gov Identifier: NCT03193801
Recruitment Status : Not yet recruiting
First Posted : June 21, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Mitral Valve Insufficiency Mitral Valve Disease Mitral Valve Regurgitation Heart Failure Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX

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).

Study Design

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
Anticipated Study Start Date : October 2017
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2024
Arms and Interventions

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


Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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

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 or greater 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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT03193801


Contacts
Contact: Justine Encabo 949-250-3502 Justine_Encabo@edwards.com
Contact: Vinny Podichetty, MD 949-250-5794 Vinny_Podichetty@edwards.com

Sponsors and Collaborators
Edwards Lifesciences
More Information

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03193801     History of Changes
Other Study ID Numbers: 2015-08 MVIV
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Edwards Lifesciences:
SAPIEN 3
PARTNER 3
cardiovascular disease
TMVR
failing valve
failing bioprosthetic valve

Additional relevant MeSH terms:
Heart Failure
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases