NCT07321899

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,186

participants targeted

Target at P75+ for not_applicable

Timeline
181mo left

Started Jun 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2031

9.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2041

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

5.3 years

First QC Date

January 5, 2026

Last Update Submit

January 6, 2026

Conditions

Severe Tricuspid Regurgitation

Keywords

Tricuspid RegurgitationSymptomatic tricuspid regurgitationHeart valve diseaseStructural heart interventionSevere valve diseaseRandomized controlled trialtricuspid insufficiencytricuspid diseasetricuspid valve disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Tricuspid regurgitation (TR) grade reduction

    6 months post-procedure

  • Change in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline

    6 months post-procedure

  • All-cause mortality

    12 months post-procedure

  • Heart failure hospitalization

    12 months post-procedure

  • New onset conduction disturbance (NOCD)

    30 days post-procedure

  • +2 more secondary outcomes

Study Arms (3)

Medtronic Intrepid™ TTVR

EXPERIMENTAL

Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation.

Device: Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System

Edwards EVOQUE TTVR

ACTIVE COMPARATOR

Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR in patients with severe or greater tricuspid regurgitation.

Device: Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System

Single Arm Registry

EXPERIMENTAL

Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation who are not eligible for randomization.

Device: Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System

Interventions

Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) SystemDEVICE

Transcatheter Tricuspid Valve Replacement

Medtronic Intrepid™ TTVRSingle Arm Registry
Edwards EVOQUE Tricuspid Valve Replacement (TTVR) SystemDEVICE

Transcatheter Tricuspid Valve Replacement

Edwards EVOQUE TTVR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Any tricuspid device currently in place.
  • Anatomic contraindications.
  • Need for emergent or urgent surgery.
  • Left ventricular ejection fraction \<25%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tricuspid Valve InsufficiencyHeart Valve Diseases

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Vinayak N. Bapat, MD

    Minneapolis Heart Institute

    PRINCIPAL INVESTIGATOR

  • Anita Asgar, MD

    Northwestern Medicine Bluhm Cardiovascular Institute

    PRINCIPAL INVESTIGATOR

  • Nicolas Dumonteil, MD

    Clinique Pasteur Groupe CardioVasculaire Interventionnel

    PRINCIPAL INVESTIGATOR

  • Azeem Latib, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

  • Firas Zahr, MD

    Knight Cardiovascular Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amber St Martin

CONTACT

612-380-5637rs.pathfinder@medtronic.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 7, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2031

Study Completion (Estimated)

April 1, 2041

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share