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
22 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

Start date
Feb 19, 2024
Status verified
Jun 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2030

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

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 (6)

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
Providence Heart InstitutePortlandOregon97225
Angela Redd
[email protected]
503-216-2170
Vanderbilt University Medical CenterNashvilleTennessee37203
Temika Battle
[email protected]
615-322-5036

Find similar trials in Tucson, AZ

By research site
Tucson Medical Center· Tucson, AZKaiser Permanente· San Francisco, CAPiedmont Hospital· Atlanta, GAMayo Clinic· Rochester, MNProvidence Heart Institute· Portland, ORVanderbilt University Medical Center· Nashville, TN

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