Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2020-10-20
2031-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Primary Cohort
Device: Intrepid TTVR System
Intrepid™ TTVR System
Device: Intrepid™ TTVR System
Interventions
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Intrepid™ TTVR System
Device: Intrepid™ TTVR System
Eligibility Criteria
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Inclusion Criteria
* Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team
* Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE)
* New York Heart Association (NYHA) Function Class II or greater
* Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access
* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
* Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
Exclusion Criteria
* Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)
* Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus
* Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system
* Echocardiographic evidence of severe right ventricular dysfunction
* Left ventricular ejection fraction (LVEF) \<30 as measured by resting echocardiogram within 30 days of the Index Procedure
* Need for emergent or urgent surgery
* Untreated clinically significant coronary artery disease requiring revascularization
* Carcinoid tricuspid regurgitation
18 Years
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Providence Saint Patrick Hospital
Missoula, Montana, United States
The Mount Sinai Hospital
New York, New York, United States
New York-Presbyterian Hospital Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
Oregon Health & Science University Hospital
Portland, Oregon, United States
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, United States
Houston Methodist Hospital
Houston, Texas, United States
Aurora Saint Lukes Medical Center
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Kathy Phillips
Role: primary
Jessica Byrne
Role: primary
Niharika Ikkurthy
Role: primary
Milena Ferreira
Role: primary
Jill Cloutier
Role: primary
Elizabeth Charles
Role: primary
Keoni Fordham
Role: primary
Elizabeth Helm
Role: primary
Jennifer Nguyen
Role: primary
Christina Michael
Role: primary
Favio Herbas
Role: primary
Lisbeth Martinez
Role: primary
Angela Yang
Role: primary
Belinda Susie Frakes
Role: primary
Lacey Maclay
Role: primary
Martha Slyman
Role: primary
Ashtyn Chamberland
Role: primary
Brittany Mashuda
Role: primary
Tia McGaughy
Role: primary
Dena Burke
Role: primary
Other Identifiers
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MDT20009TMV003
Identifier Type: -
Identifier Source: org_study_id