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NCT Number: NCT07321899

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

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.

Recruiting

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Key information

Conditions

Severe Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abrazo Arizona Heart Hospital, Phoenix, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System

Device

Transcatheter Tricuspid Valve Replacement

Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System

Device

Transcatheter Tricuspid Valve Replacement

Primary outcomes

  1. Rate of Major Adverse Events (MAE)

    Time frame: 30-days post-procedure

  2. Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention

    Time frame: 1-year post-procedure

Secondary outcomes

  1. Tricuspid regurgitation (TR) grade reduction

    Time frame: 6 months post-procedure

    Total number of patients with at least one grade TR reduction

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

    Time frame: 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

  3. All-cause mortality

    Time frame: 12 months post-procedure

  4. Heart failure hospitalization

    Time frame: 12 months post-procedure

  5. New onset conduction disturbance (NOCD)

    Time frame: 30 days post-procedure

  6. Total procedure time

    Time frame: Procedure

  7. Right ventricle (RV) dysfunction

    Time frame: 12 months post-procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Amber St Martin

CONTACT

[email protected]

612-380-5637

Sponsors and collaborators

Lead sponsor

Medtronic Cardiovascular

Industry

Registry information

Official study title

Transcatheter Tricuspid Valve Replacement Using the Medtronic Intrepid™ TTVR System in Patients With Severe Symptomatic Tricuspid Regurgitation - PATHFINDER

Acronym: PATHFINDER

Important dates

Study start
2026
Primary completion
2031
Study completion
2041
First posted
Jan 7, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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