Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation

ConditionSevere Tricuspid Regurgitation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMedtronic Cardiovascular

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Any tricuspid device currently in place.

Anatomic contraindications.

Need for emergent or urgent surgery.

Left ventricular ejection fraction <25%.

Trial design

Treatments tested in this trial

Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System
Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System

Treatment groups

1,186 Participants

are divided into 3 treatment groups

Sponsors and collaborators

Medtronic Cardiovascular

Lead sponsor

Source ClinicalTrials.gov