TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)

Part of paid clinical trials in Carmel, Indiana.

Sponsor
Edwards Lifesciences
Study ID
NCT07684313
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular Diseases
  • Heart Diseases
  • Heart Valve Diseases
  • Tricuspid Valve Disease

Eligibility Criteria

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

Interventions

  • Edwards TRIFORMIS RESILIA heart valve — DEVICE
    Surgical replacement of the tricuspid valve with the Edwards TRIFORMIS RESILIA heart valve

Study Details

TRIBLAZE is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in a minimum of 75 participants who will receive the Edwards Lifesciences TRIFORMIS RESILIA surgical tricuspid heart valve, Model 11300T.

Key Dates

Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2030
Completion
Dec 31, 2034

Study Design

Enrollment
75 participants (estimated)

Arms

  • Arm: Edwards TRIFORMIS RESILIA heart valve
    Subjects who were treated with the Edwards TRIFORMIS RESILIA heart valve

Primary Outcome Measure

Participant's average mean gradient measurement over time [ Time Frame: 1 Year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ascension St. Vincent's HospitalCarmelIndiana46260
David Heimansohn, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Carmel, IN

By research site
Ascension St. Vincent's Hospital· Carmel, IN

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