Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Laplace Interventional, Inc
Study ID
NCT06183684
Status
Recruiting
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Conditions

  • Tricuspid Regurgitation

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Laplace TTVR System — DEVICE
    Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of severe, symptomatic tricuspid regurgitation

Study Details

The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Key Dates

First listed
Dec 27, 2023
Start date
Feb 19, 2024
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2032

Study Design

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

Arms

  • Experimental: Tricuspid Valve Replacement
    Transcatheter replacement of the native tricuspid valve with the Laplace bioprosthesis

Primary Outcome Measure

Technical success [ Time Frame: During procedure ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Tucson Medical CenterTucsonArizona85712
Kaiser PermanenteSan FranciscoCalifornia94118
Cristina Casias, RN
[email protected]
4158332247
Piedmont HospitalAtlantaGeorgia30309
Amy Autry-Bush
904-673-6220
Mayo ClinicRochesterMinnesota55905
Structural Heart Research Team
507-255-6133
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756
Kalee Cook
[email protected]
603-650-6228
Montefiore Medical CenterThe BronxNew York10641
Tammy Guzman
[email protected]
718-920-4595
University Hospitals, Cleveland Medical CenterClevelandOhio44106
Nisreen Zueiter
[email protected]
216-844-3801
Oklahoma Heart InstituteTulsaOklahoma74104
Ashlee Ritter
[email protected]
918-579-5865
Providence Heart InstitutePortlandOregon97225
Angela Redd
[email protected]
503-216-2170
Vanderbilt University Medical CenterNashvilleTennessee37203
Temika Battle
[email protected]
615-322-5036

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Tucson Medical Center· Tucson, AZKaiser Permanente· San Francisco, CAPiedmont Hospital· Atlanta, GAMayo Clinic· Rochester, MNDartmouth-Hitchcock Medical Center· Lebanon, NHMontefiore Medical Center· The Bronx, NY

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