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TRILUMINATE Pivotal Trial

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: NCT03904147
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).

Condition or disease Intervention/treatment Phase
Tricuspid Regurgitation Device: Tricuspid valve repair Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : March 2027

Arm Intervention/treatment
Experimental: Roll-In
TriClip Device treatment for physicians requiring additional training prior to beginning randomized cohort enrollment.
Device: Tricuspid valve repair
Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation

Active Comparator: Randomized Cohort
TriClip (Device) Group vs. Medical Therapy (Control) Group
Device: Tricuspid valve repair
Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation

Experimental: Single Arm
Subjects in which it is believed TR is not going to be reduced to moderate or less severity will receive the TriClip device.
Device: Tricuspid valve repair
Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation




Primary Outcome Measures :
  1. Hierarchical composite of number of participants with all-cause mortality or number of participants with tricuspid valve surgery, rate of heart failure hospitalizations, and assessment of quality of life improvement using the KCCQ [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Change in TR from severe to moderate or less [ Time Frame: 30 Days ]
  2. Freedom from major adverse events (MAE) occurring after procedure attempt [ Time Frame: 30 Days ]
  3. Change in Quality of Life as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Score [ Time Frame: 12 Months ]
    KCCQ score ranges from 0 to 100, with 100 representing the least burden of symptoms

  4. Change in 6 Minute Walk Test (6MWT) [ Time Frame: 12 Months ]


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

Inclusion Criteria:

  • In the judgment of the sites local heart team, subject has been adequately treated per applicable standards (including medical management) and stable for at least 30 days as follows:

    • Optimized medical therapy for treatment of TR (e.g. diuretics).
    • Medical and/or device therapy, for mitral regurgitation, atrial fibrillation, coronary artery disease and heart failure.
    • The Eligibility Committee will confirm that the subject has been adequately treated medically.
  • Subject is symptomatic with Severe TR despite being optimally treated as described above. TR severity is determined by the assessment of a qualifying TTE and confirmed by the ECL. The ECL may request a TEE to confirm TR etiology. Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after the cardiac procedure(s).
  • The cardiac surgeon of the Site Heart Team concur that the patient is at intermediate or greater estimated risk of mortality with tricuspid valve surgery.
  • New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV
  • In the judgment of the TriClip(TM) implanting Investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter.
  • Age ≥18 years at time of consent.
  • Subject must provide written informed consent prior to any trial related procedure.

Exclusion Criteria:

  • Systolic pulmonary artery pressure (sPAP) > 70 mmHg or fixed pre-capillary pulmonary hypertension as assessed by right heart catheterization (RHC)
  • Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mm Hg)
  • Any prior tricuspid valve procedure that would interfere with placement of the TriClip(TM) device
  • Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction prior 60 days). Note: Patients with concomitant Mitral and tricuspid valve disease will have the option of getting their MR treated, and wait 60 days prior to being reassessed for the trial.
  • Pacemaker or ICD leads that would prevent appropriate placement of the TriClip(TM) device.
  • Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 1.0 cm2 and/or mean gradient ≥5 mmHg as measured by the ECL
  • Left Ventricular Ejection Fraction (LVEF) ≤20%
  • Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:

    • Evidence of calcification in the grasping area
    • Presence of a severe coaptation defect (> 2cm) of the tricuspid leaflets
    • Severe leaflet defect(s) preventing proper device placement
    • Ebstein Anomaly - Identified by having a normal annulus position while the valve leaflets are attached to the walls and septum of the right ventricle.
  • Tricuspid valve anatomy not evaluable by TTE and TEE
  • Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated).
  • MI or known unstable angina within prior 30 days
  • Percutaneous coronary intervention within prior 30 days
  • Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
  • Cerebrovascular Accident (CVA) within prior 90 days
  • Chronic dialysis
  • Bleeding disorders or hypercoagulable state
  • Active peptic ulcer or active gastrointestinal (GI) bleeding
  • Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant therapy.

    • Note: Contraindication to either antiplatelet or anticoagulant therapy (individually not both therapies) is not an exclusion criterion.
  • Ongoing infection requiring current antibiotic therapy (if temporary illness, patients may enroll 30 days after discontinuation of antibiotics with no active infection).
  • Known allergy or hypersensitivity to device materials
  • Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
  • Life expectancy of less than 12 months
  • Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
  • Subject is currently participating in another clinical investigation for valvular heart disease(s).
  • Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Female subjects of child-bearing potential are required to have a negative pregnancy test done within 7 days of the baseline visit per site standard test. Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.) It is accepted, in certain cases, to include subjects having a sterilized regular partner or subjects using a double barrier contraceptive method.
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

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): NCT03904147


Contacts
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Contact: Brian Crowe 651-756-2783 brian.crowe@abbott.com

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Locations
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United States, Alabama
University Hospital - University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Katherine Phillips    205-975-9426    kcphillips@uabmc.edu   
Principal Investigator: Mustafa Ahmed         
United States, Arizona
Banner-University Medical Center Phoenix Not yet recruiting
Phoenix, Arizona, United States, 85006
Contact: James Schohn    602-839-5775    jschohn@email.arizona.edu   
Principal Investigator: Ashish Pershad         
Arizona Cardiovascular Research Center Recruiting
Phoenix, Arizona, United States, 85016
Contact: Sophie Raymond    602-456-2342    sraymond@azheartrhythm.com   
Principal Investigator: Hursh Naik         
Phoenix Cardiovascular Research Group Not yet recruiting
Phoenix, Arizona, United States, 85018
Contact: Jessica Byrne    480-619-2754    jessica.byrne@abrazohealth.com   
Principal Investigator: Timothy Byrne         
Scottsdale Healthcare Shea Not yet recruiting
Scottsdale, Arizona, United States, 85260
Contact: Joanne Saczynski    480-323-3390    JoAnne.Saczynski@honorhealth.com   
Principal Investigator: David Rizik         
United States, California
Scripps Green Hospital Not yet recruiting
La Jolla, California, United States, 92037
Contact: Chelsea Butler    858-824-5241    butler.chelsea@scrippshealth.org   
Principal Investigator: Matthew Price         
USC University Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: Melissa Ramos    323-442-7983    melissa.ramos@med.usc.edu   
Principal Investigator: Steven Burstein         
Cedars-Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Mane Arabyan    310-248-8515    Mane.Arabyan@cshs.org   
Principal Investigator: Raj Makkar         
El Camino Hospital Not yet recruiting
Mountain View, California, United States, 94040
Contact: Janet Lamm    650-962-4566    Janet_Lamm@elcaminohospital.org   
Principal Investigator: Chad Rammohan         
St. Joseph Hospital Not yet recruiting
Orange, California, United States, 92868
Contact: Linda Gozar    714-992-3000    Linda.Gozar@stjoe.org   
Principal Investigator: Aidan Raney         
Sutter Medical Center, Sacramento Not yet recruiting
Sacramento, California, United States, 95816
Contact: Beverly Seiler    916-877-4173    seilerb@sutterhealth.org   
Principal Investigator: Pei-Hsiu Huang         
University of California - Davis Medical Center Not yet recruiting
Sacramento, California, United States, 95817
Contact: Kimberly Book    916-734-5639    kabook@ucdavis.edu   
Principal Investigator: Gagan Singh         
Kaiser Foundation Hospital Not yet recruiting
San Francisco, California, United States, 94115
Contact: Quyen Chau    415-833-3468    Quyen.X.Chau@kp.org   
Principal Investigator: Jacob Mishell         
United States, Colorado
University of Colorado Hospital Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Therese Jones    303-724-6473    Therese.l.jones@ucdenver.edu   
Principal Investigator: John Carroll         
United States, Florida
JFK Medical Center Not yet recruiting
Atlantis, Florida, United States, 33462
Contact: Donna Roberts    561-548-1968    Donna.Roberts@HCAhealthcare.com   
Principal Investigator: Marcos Nores         
Manatee Memorial Hospital Not yet recruiting
Bradenton, Florida, United States, 34208
Contact: Sarah Stannard    941-748-2277    sarah.stannard@uhsinc.com   
Principal Investigator: Alessandro Golino         
Morton Plant Valve Clinic Not yet recruiting
Clearwater, Florida, United States, 33756
Contact: Sue Fisher    727-489-2552    Susan.Fisher1@baycare.org   
Principal Investigator: Joshua Rovin         
Delray Medical Center Not yet recruiting
Delray Beach, Florida, United States, 33484
Contact: Donna Cabral    561-495-3238    donna.cabral@tenethealth.com   
Principal Investigator: Brijeshwar Maini         
Baptist Hospital of Miami Not yet recruiting
Miami, Florida, United States, 33176
Contact: Maria Ines Ardid    786-596-6258    MariaAr@baptisthealth.net   
Principal Investigator: Ramon Quesada         
Palm Beach Garden Medical Center Not yet recruiting
Palm Beach Gardens, Florida, United States, 33410
Contact: Lisa Wettermann    561-799-5431    elizabeth.wettermann@tenethealth.com   
Principal Investigator: Saurabh Sanon         
Tallahassee Research Institute Not yet recruiting
Tallahassee, Florida, United States, 32308
Contact: Rebecca Plasay    850-431-5024    Rebecca.plasay@tmh.org   
Principal Investigator: Thomas Noel         
United States, Georgia
Piedmont Heart Institute Not yet recruiting
Atlanta, Georgia, United States, 30309
Contact: Caryn Bernstein    404-605-5688    caryn.bernstein@piedmont.org   
Principal Investigator: Vivek Rajagopal         
United States, Illinois
Northwestern Memorial Hospital Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Anna Huskin    312-695-4067    Anna.huskin@nm.org   
Principal Investigator: Mark Ricciardi         
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Kelli Jones    312-942-8707    Kelli_Jones@rush.edu   
Principal Investigator: Clifford Kavinsky         
Advocate Health and Hospitals Corporation Not yet recruiting
Oakbrook Terrace, Illinois, United States, 60181
Contact: Jillian Lux    630-785-2674    Jillian.Lux@advocatehealth.com   
Principal Investigator: Mark Goodwin         
United States, Indiana
St. Vincent Hospital Not yet recruiting
Indianapolis, Indiana, United States, 46240
Contact: Melanie Glover    317-338-8042    melanie.wheeler@ascension.org   
Principal Investigator: James Hermiller         
United States, Kansas
Kansas University Medical Center Not yet recruiting
Kansas City, Kansas, United States, 66160
Contact: Tilitha Shawgo    913-588-9720    tshawgo@kumc.edu   
Principal Investigator: Peter Tadros         
Cardiovascular Research Institute of Kansas Recruiting
Wichita, Kansas, United States, 67226
Contact: Elizabeth Persels    316-219-4112    elizabeth.persels@cckheart.com   
Principal Investigator: Bassem Chehab         
United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Lisa Downey    617-732-4812    ldowney2@bwh.harvard.edu   
Principal Investigator: Pinak Shah         
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Jenifer Kaufman    617-632-8956    jmkaufma@bidmc.harvard.edu   
Principal Investigator: Roger Laham         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48104
Contact: Jessica Oakley    734-232-9051    joakley@med.umich.edu   
Principal Investigator: Stanley Chetcuti         
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Kate Jappe    612-863-7347    Kate.Jappe@allina.com   
Principal Investigator: Paul Sorajja         
United States, Missouri
St. Luke's Hospital Not yet recruiting
Kansas City, Missouri, United States, 64111
Contact: Alicia Roberts    816-932-5987    aroberts@saint-lukes.org   
Principal Investigator: Adnan Chhatriwalla         
United States, New York
Albany Medical Center Not yet recruiting
Albany, New York, United States, 12208
Contact: Amanda O'Malley    518-292-6236    aomalley@capitalcardiology.com   
Principal Investigator: Augustin Delago         
Montefiore Medical Center - Moses Division Not yet recruiting
Bronx, New York, United States, 10467
Contact: John Lucaj    718-920-8576    jlucaj@montefiore.org   
Principal Investigator: Azeem Latib         
Buffalo General Hospital Not yet recruiting
Buffalo, New York, United States, 14203
Contact: Robin Stein    716-888-4859    rmstein3@buffalo.edu   
Principal Investigator: Vijay Iyer         
North Shore University Hospital Not yet recruiting
Manhasset, New York, United States, 11030
Contact: Kristine Mcgowan    516-562-2345    KMcGowan@northwell.edu   
Principal Investigator: Bruce Rutkin         
New York University Hospital Not yet recruiting
New York, New York, United States, 10016
Contact: Danielle Sin    646-501-0264    Danielle.Sin@nyumc.org   
Principal Investigator: Mathew Williams         
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: Jason Storch    212-241-4424    jason.storch@mountsinai.org   
Principal Investigator: Gilbert Tang         
New York-Presbyterian/Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Kate Dalton    212-342-1820    keb2114@columbia.edu   
Principal Investigator: Susheel Kodali         
United States, North Carolina
Carolinas Medical Center Not yet recruiting
Charlotte, North Carolina, United States, 28203
Contact: Sally Aberle    704-355-4794    Sally.Aberle@atriumhealth.org   
Principal Investigator: Jonathan Schwartz         
Novant Health Heart and Vascular Research Institute Not yet recruiting
Charlotte, North Carolina, United States, 28204
Contact: Pailing Richards    704-264-1400    pcrichards@novanthealth.org   
Principal Investigator: Oluseun Alli         
United States, Ohio
Christ Hospital Not yet recruiting
Cincinnati, Ohio, United States, 45219
Contact: Linda Martin    513-585-1777    linda.martin@thechristhospital.com   
Principal Investigator: Ian Sarembock         
The Cleveland Clinic Foundation Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Susan Hejl    216-445-6817    hejls@ccf.org   
Principal Investigator: Samir Kapadia         
Ohio Health Research Institute Not yet recruiting
Columbus, Ohio, United States, 43214
Contact: Ana Maria Gomez Ramirez    614-566-1266    AnaMaria.GomezRamirez@OhioHealth.com   
Principal Investigator: Carlos Sanchez         
United States, Pennsylvania
Hospital of the University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Suveeksha Naidu    215-662-6590    Suveeksha.Naidu@uphs.upenn.edu   
Principal Investigator: Howard Herrmann         
Allegheny General Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Tracy Spirk    412-359-4025    tracy.spirk@ahn.org   
Principal Investigator: Walter Mcgregor         
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Melissa Enlow    412-647-1582    enlowms@upmc.edu   
Principal Investigator: Conrad Smith         
United States, Tennessee
St. Thomas Hospital Not yet recruiting
Nashville, Tennessee, United States, 37205
Contact: Jan Orga    615-222-3083    jan.orga@ascension.org   
Principal Investigator: Andrew Morse         
United States, Texas
Austin Heart Recruiting
Austin, Texas, United States, 78756
Contact: Paige Castaneda    512-421-3851    Paige.Castaneda@hcahealthcare.com   
Principal Investigator: Frank Zidar         
Baylor Jack and Jane Hamilton Heart and Vascular Hospital Not yet recruiting
Dallas, Texas, United States, 75226
Contact: Susan Aston    214-820-7358    susan.aston@bswhealth.org   
Principal Investigator: James Choi         
Memorial Hermann Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: Carmen Duron    713-500-5214    maria.carmen.duron@uth.tmc.edu   
Principal Investigator: Richard Smalling         
Methodist Hospital of San Antonio Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Gloria Carreon    210-575-3064    gloria.carreon@mhshealth.com   
Principal Investigator: Dan Donovan         
United States, Utah
Intermountain Medical Center Not yet recruiting
Murray, Utah, United States, 84157
Contact: Hannah Bezdjian    801-507-4769    hannah.bezdjian@imail.org   
Principal Investigator: Brian Whisenant         
United States, Virginia
University of Virginia Medical Center Not yet recruiting
Charlottesville, Virginia, United States, 22908
Contact: Linda Bailes    434-982-1058    lgs2m@virginia.edu   
Principal Investigator: Scott Lim         
Sentara Norfolk General Hospital Not yet recruiting
Norfolk, Virginia, United States, 23507
Contact: Chelle Zulick    757-388-1695    mrzulick@sentara.com   
Principal Investigator: Paul Mahoney         
United States, Washington
Swedish Medical Center Not yet recruiting
Seattle, Washington, United States, 98107
Contact: Jennifer Nagel    206-386-6462    jennifer.nagel@swedish.org   
Principal Investigator: Sameer Gafoor         
University of Washington Medical Center Not yet recruiting
Seattle, Washington, United States, 98195
Contact: Fatima Ranjbaran    206-221-9154    fatimar@uw.edu   
Principal Investigator: Mark Reisman         
United States, Wisconsin
Aurora Medical Group Not yet recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Jodi Kresa    414-649-3546    Jodi.Kresa@aurora.org   
Principal Investigator: Tanvir Bajwa         
Canada, British Columbia
St. Paul's Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 2E8
Contact: Elizabeth Grieve    (604) 682-2344    EGrieve@providencehealth.bc.ca   
Principal Investigator: Robert Boone         
Canada, Ontario
Hamilton Health Science Centre Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Chris Beck       beckc@HHSC.CA   
Principal Investigator: Shamir Mehta         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Ivana Kandic       Ivana.Kandic@unityhealth.to   
Principal Investigator: Neil Fam         
Sunnybrook Health Science Centre Not yet recruiting
Toronto, Ontario, Canada, M5N 3M5
Contact: Sulagna Sarker    416-480-6100    sulagna.sarker@sunnybrook.ca   
Principal Investigator: Andrew Czarnecki         
Canada, Quebec
Institut de Cardiologie de Montreal (Montreal Heart Inst.) Not yet recruiting
Montréal, Quebec, Canada, H1T 1C8
Contact: Patricia Blaise       patricia.blaise@icm-mhi.org   
Principal Investigator: Anita Asgar         
Sponsors and Collaborators
Abbott Medical Devices

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03904147     History of Changes
Other Study ID Numbers: CRD_946
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases