Recruiting

TRIFORMIS RESILIA

Sponsor:

Edwards Lifesciences

Code:

NCT07684313

Conditions

Heart Valve Diseases

Heart Diseases

Cardiovascular Diseases

Tricuspid Valve Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Edwards TRIFORMIS RESILIA heart valve

Study Details

Brief summary:

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.

Conditions

Heart Valve Diseases

Heart Diseases

Cardiovascular Diseases

Tricuspid Valve Disease

Study ID

NCT07684313

Start date

Sep 22, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2034

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years or older
  • Indication for TRIFORMIS valve implant for native or prosthetic valve dysfunction
  • Provide written informed consent prior to the 30-day imaging follow-up
  • Willing and able to return for scheduled follow-up visits

Exclusion Criteria:

• Untreatable hypersensitivity to nitinol alloys (nickel and titanium)

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

Edwards TRIFORMIS RESILIA heart valve

Subjects who were treated with the Edwards TRIFORMIS RESILIA heart valve

Interventions

Edwards TRIFORMIS RESILIA heart valve

Surgical replacement of the tricuspid valve with the Edwards TRIFORMIS RESILIA heart valve

Primary outcome measure

  • Participant's average mean gradient measurement over time [ Time Frame: 1 Year ]
  • Participant's average peak gradient measurement over time [ Time Frame: 1 Year ]
  • Participant's average Effective Orifice Area (EOA) measurement over time [ Time Frame: 1 Year ]
  • Participant's amount of tricuspid valvular regurgitation measurement over time [ Time Frame: 1 Year ]
  • Participant's right ventricular function over time [ Time Frame: 1 Year ]
  • Participant's amount of paravalvular leak over time [ Time Frame: 1 Year ]
  • Participant's quality of life improvement as measured on the Kansas City Cardiomyopathy Questionnaire from baseline to 1 year [ Time Frame: Baseline and 1 Year ]

Central Contacts and Locations

Central contacts

Aya Westbrook, PhD

949-250-2500Aya_Westbrook@edwards.com

Locations

Ascension St. Vincent's Hospital

Recruiting

Carmel, Indiana, United States, 46260

Principal Investigator:

David Heimansohn, MD

More Information

Sponsor

Edwards Lifesciences

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Edwards Lifesciences on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.