VDyne Transcatheter Tricuspid Valve Replacement Study To Evaluate Safety And Clinical Efficacy In Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)

Overview

About this study

Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

* Age ≥18 years old
* Subject is willing and able to comply with all study evaluations and provide consent
* Subject must agree not to participate in any other clinical trial for a period of one year following index procedure
* New York Heart Association (NYHA) Functional Class II, III, or IV and ambulatory
* At least severe symptomatic tricuspid regurgitation.
* Despite adequate and Optimized Medical Therapy (OMT), subject has signs and symptoms from TR, or prior heart failure hospitalization from TR
* Heart team determines that the subject is appropriate for transcatheter tricuspid valve replacement
* Functional and/or degenerative TR graded as at least severe

Exclusion Criteria:

* Subject unable or unwilling to comply with study required testing and follow-up visits
* Subject is currently participating in another clinical trial (drug, biologic, or device) that has not yet completed its primary endpoint or is likely to interfere with this study
* Pregnant, lactating subjects, and /or those who plan pregnancy in the period up to one year following index procedure.
* Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anticoagulation, etc.) which cannot be adequately managed medically
* Life expectancy ≤12 months due to non-cardiac comorbidities
* Current IV Drug user (must be free from drug abuse for ≥1 year)
* Subject unable or unwilling to provide written, informed consent before study enrollment
* Tricuspid valve anatomy (cardiac and vascular) that is not suitable for the VDyne System
* Hypersensitivity to metals (such as nickel or titanium)
* Prior tricuspid valve surgery or catheter-based therapy with permanent residual device(s) implanted that would preclude delivery or implantation of the VDyne valve (e.g., valve replacement, edge to edge repair, etc.)
* Severe valvular heart disease using established echocardiographic criteria requiring intervention other than the tricuspid valve
* Known significant intracardiac shunt (e.g., septal defect).
* Cerebrovascular accident (stroke, TIA) within 90 days of treatment procedure
* Severe lung disease (severe COPD) or continuous use of home oxygen or oral steroids
* Acute myocardial infarction (AMI) within 30 days of SSC determination of eligibility
* Leukopenia, chronic anemia (Hgb \< 9 g/dL), current thrombocytopenia (platelets \<70/mcL), history of bleeding diathesis, or coagulopathy
* Unwilling to receive blood products
* Deep vein thrombosis and/or pulmonary embolism in the last 6-months

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mackram Eleid, M.D.

Open for enrollment

Contact information:

Barret Boyer

5075388243

boyer.barret@mayo.edu

More information

Publications

  • Tricuspid regurgitation (TR) is a prevalent, often overlooked condition linked to significant morbidity and mortality in older adults. Due to the high risks associated with conventional surgery, transcatheter tricuspid valve replacement (TTVR) has emerged as a less invasive alternative. This systematic review and meta-analysis evaluated the clinical outcomes and echocardiographic indices of TTVR. Read More on PubMed
  • Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed. Read More on PubMed
  • Severe tricuspid regurgitation (TR) often causes substantial impairment in patient-reported health status (ie, symptoms, physical and social function, and quality of life), which may improve with transcatheter tricuspid valve replacement (TTVR). Read More on PubMed
  • The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the EVOQUE tricuspid valve replacement system and its impact on short-term clinical outcomes. Read More on PubMed