Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03242642

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Mitral Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Columbian Hospital, New Westminster, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Moderate to severe or severe symptomatic mitral regurgitation
  • Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention

Exclusion criteria

  • prior transcatheter mitral valve procedure with device currently implanted
  • anatomic contraindications
  • prohibitive mitral annular calcification
  • left ventricular ejection fraction <25%
  • need for emergent or urgent surgery
  • hemodynamic instability

Treatment and study plan

Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

Device

mitral valve replacement

Primary outcomes

  1. Primary Cohort

    Time frame: 1 year

    Composite of all-cause mortality or heart failure hospitalization

  2. MAC Cohort

    Time frame: 1 year

    All-cause mortality

Secondary outcomes

  1. All-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding

    Time frame: 30 days or hospital discharge (whichever is later)

    Composite

  2. Degree of mitral regurgitation

    Time frame: 6 months

    measured by echocardiography

  3. Quality of Life Improvement

    Time frame: 3 months (KCCQ)

    measured by KCCQ

  4. Change in New York Heart Association Class

    Time frame: 30 days

    change in NYHA Class

  5. Echocardiographic assessments of degree mitral valve regurgitation

    Time frame: 1 year

    measured by echocardiography

  6. Cardiovascular hospitalizations

    Time frame: 1 year

    cardiovascular hospitalizations

Study contacts

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

Megan Wilder Fredrickson

CONTACT

[email protected]

612-469-1749

Sponsors and collaborators

Lead sponsor

Medtronic Cardiovascular

Industry

Registry information

Official study title

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial

Acronym: APOLLO

Important dates

Study start
2017
Primary completion
2027
Study completion
2036
First posted
Aug 8, 2017
Registry last updated
Jun 29, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.