An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Part of paid clinical trials in Tucson, Arizona.

Sponsor
HighLife SAS
Study ID
NCT04029337
Status
Recruiting
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Conditions

  • Mitral Regurgitation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcatheter Mitral Valve Replacement — DEVICE
    Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system

Study Details

Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.

Key Dates

Start date
Jul 14, 2020
Status verified
Mar 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Transcatheter Mitral Valve Replacement
    HighLife TMVR System is a novel and innovative approach developed as an alternative treatment for severe MR when medical treatment is maximal and surgical interventions not possible or at high risk. The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a sub-annular implant (SAI), and their delivery systems and loading tools.

Primary Outcome Measure

Freedom of major adverse events [ Time Frame: at 30 days post procedure ]

Locations (10)

FacilityCityStateZIPSite coordinators
Tucson Medical CenterTucsonArizona85712
Thomas Waggoner, MD
Thomas Waggoner <[email protected]>
+1 520-838-3540
Los Robles Regional Medical CenterLos AngelesCalifornia91360
Saibal Kar, MD
[email protected]
(805) 497-2727
Saibal Kar, MD (PRINCIPAL_INVESTIGATOR)
Piedmont HeartAtlantaGeorgia30309
Pradeep Yadav, MD
[email protected]
(404) 605-5000
Pradeep Yadav, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Pinank Shah, MD
[email protected]
+1 857-307-4000
Minneapolis HeartMinneapolisMinnesota55407
Paul Sorajja, MD
[email protected]
(612) 863-3900
Paul Sorajja, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterNew YorkNew York10467
Azeem Latib, MD
[email protected]
(718) 920-4321
Azim Latib, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Medical University of South CarolinaCharlestonSouth Carolina29425
Daniel Steinberg, MD
[email protected]
(843) 792-1414
Daniel Steinberg, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Sachin Goel, MD
[email protected]
(713) 790-3311
Sachin Goel, MD (PRINCIPAL_INVESTIGATOR)
Chippenham Hospital RichmondRichmondVirginia23225-

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By research site
Tucson Medical Center· Tucson, AZLos Robles Regional Medical Center· Los Angeles, CAPiedmont Heart· Atlanta, GABrigham and Women's Hospital· Boston, MAMinneapolis Heart· Minneapolis, MNMontefiore Medical Center· New York, NY

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