The TRICURE EFS Study

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
TRiCares
Study ID
NCT06506942
Status
Recruiting
Apply to this trial

Conditions

  • Cardiovascular Diseases
  • Heart Valve Diseases
  • Tricuspid Valve Regurgitation

Eligibility Criteria

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

Interventions

  • Transcatheter Tricuspid Valve Replacement — DEVICE
    Replacement of the tricuspid valve through a transcatheter approach

Study Details

Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Key Dates

Start date
Sep 11, 2024
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2031

Study Design

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

Arms

  • Experimental: Transcatheter Tricuspid Valve Replacement
    Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System

Primary Outcome Measure

Composite of MAE [ Time Frame: 30 day post-intervention ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Piedmont Healthcare Inc.AtlantaGeorgia30309
Pradeep Yadav, MD
[email protected]
404-605-6517
Pradeep Yadav, MD (PRINCIPAL_INVESTIGATOR)
NorthwesternChicagoIllinois60611
Anita Asgar, MD
[email protected]
312-664-3278
Anita Asgar, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan Hospital and Health SystemsAnn ArborMichigan48109
Gorav Ailawadi, MD
[email protected]
734-936-4974
Gorav Ailawadi, MD (PRINCIPAL_INVESTIGATOR)
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407
Vinayak Bapat, MD
[email protected]
612-863-6900
Jason Digman
[email protected]
Vinayak Bapat, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Medical Center/ NewYork Presbyterian HospitalNew YorkNew York10032
Susheel Kodali, MD
[email protected]
212-342-0444
Susheel Kodali, MD (PRINCIPAL_INVESTIGATOR)
MontefioreThe BronxNew York10461
Azeem Latib, MD
[email protected]
718-920-4212
Azeem Latib, MD (PRINCIPAL_INVESTIGATOR)
The Christ HospitalCincinnatiOhio45219
Santiago Garcia, MD
[email protected]
513-206-1222
Santiago Garcia, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Nicholas S. Amoroso, MD
[email protected]
843-876-0940
Nicholas S. Amoroso, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Piedmont Healthcare Inc.· Atlanta, GANorthwestern· Chicago, ILUniversity of Michigan Hospital and Health Systems· Ann Arbor, MIMinneapolis Heart Institute Foundation· Minneapolis, MNColumbia University Medical Center/ NewYork Presbyterian Hospital· New York, NYMontefiore· The Bronx, NY

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