Severe Tricuspid Regurgitation
Conditions
Keywords
Tricuspid Regurgitation, Symptomatic tricuspid regurgitation, Heart valve disease, Structural heart intervention, Severe valve disease, Randomized controlled trial, tricuspid insufficiency, tricuspid disease, tricuspid valve disease
Brief summary
This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.
Detailed description
Prospective, global, pre-market, interventional, multi-center, randomized controlled pivotal trial to evaluate the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System compared to Edwards EVOQUE TTVR System in symptomatic patients with severe or greater tricuspid regurgitation.
Interventions
DEVICEMedtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System
Transcatheter Tricuspid Valve Replacement
DEVICEEdwards EVOQUE Tricuspid Valve Replacement (TTVR) System
Transcatheter Tricuspid Valve Replacement
Sponsors
Medtronic Cardiovascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years at the time of consent. * Severe symptomatic tricuspid regurgitation (TR) despite optimal medical therapy (OMT). * Local site multidisciplinary heart team experienced in tricuspid valve therapies agrees that the subject is appropriate for TTVR.
Exclusion criteria
* Any tricuspid device currently in place. * Anatomic contraindications. * Need for emergent or urgent surgery. * Left ventricular ejection fraction \<25%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Major Adverse Events (MAE) | 30-days post-procedure |
| Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention | 1-year post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tricuspid regurgitation (TR) grade reduction | 6 months post-procedure | Total number of patients with at least one grade TR reduction |
| Change in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline | 6 months post-procedure | KCCQ overall summary score is a patient-reported measure of health status. Scores range from 0 to 100 where higher scores reflect better quality of life |
| All-cause mortality | 12 months post-procedure | — |
| Heart failure hospitalization | 12 months post-procedure | — |
| New onset conduction disturbance (NOCD) | 30 days post-procedure | — |
| Total procedure time | Procedure | — |
| Right ventricle (RV) dysfunction | 12 months post-procedure | — |
Countries
United States
Contacts
CONTACTAmber St Martin
PRINCIPAL_INVESTIGATORVinayak N. Bapat, MD
Minneapolis Heart Institute
PRINCIPAL_INVESTIGATORAnita Asgar, MD
Northwestern Medicine Bluhm Cardiovascular Institute
PRINCIPAL_INVESTIGATORNicolas Dumonteil, MD
Clinique Pasteur Groupe CardioVasculaire Interventionnel
PRINCIPAL_INVESTIGATORAzeem Latib, MD
Montefiore Medical Center
PRINCIPAL_INVESTIGATORFiras Zahr, MD
Knight Cardiovascular Institute
Outcome results
None listed