Trisol System EFS Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
Trisol Medical
Study ID
NCT04905017
Status
Recruiting
Apply to this trial

Conditions

  • Tricuspid Regurgitation

Eligibility Criteria

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

Interventions

  • Transcatheter Tricuspid Valve Replacement — DEVICE
    Replacement of the tricusupid valve using Trisol System in a transcatheter approach

Study Details

The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).

Key Dates

Start date
Mar 2, 2022
Status verified
Jan 2025
Primary completion
Jan 1, 2026
Completion
Jul 1, 2031

Study Design

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

Arms

  • Experimental: Treatment with the Trisol System

Primary Outcome Measure

Rate of device-related serious adverse events [ Time Frame: Up to 30 days ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Rajendra Makkar, MD (PRINCIPAL_INVESTIGATOR)
Piedmont Heart InstituteAtlantaGeorgia30309
Caryn Bernstein, MN FNP-BC CCRC
[email protected]
404.605.5688
Vinod Thourani, MD (PRINCIPAL_INVESTIGATOR)
Pradeep K Yadav, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Medical Center/NYPHNew YorkNew York10032
Kate Dalton, MS, RD
[email protected]
347-514-3366
Cleveland ClinicClevelandOhio44195
Amar Krishnaswamy, MD (PRINCIPAL_INVESTIGATOR)
Main Line Health / Lankenau Institute for Medical ResearchWynnewoodPennsylvania19096
Ann Marie Chikowski, MBA, RN, CCRC
[email protected]
484.476.8579
William Gray, MD FACC FSCAI (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37203
Natalie Jackson, MPH
[email protected]
615-343-1782
Kashish Goel, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia CardiologyCharlottesvilleVirginia22908
Linda Bailes Bryceland, RN
[email protected]
434-982-1058

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAPiedmont Heart Institute· Atlanta, GAColumbia University Medical Center/NYPH· New York, NYCleveland Clinic· Cleveland, OHMain Line Health / Lankenau Institute for Medical Research· Wynnewood, PAVanderbilt University Medical Center· Nashville, TN

Related Studies