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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03242642

Acronym

APOLLO

Enrollment

1056

Registered

2017-08-08

Start date

2017-10-23

Completion date

2036-07-07

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Regurgitation

Keywords

Heart disease, valve disease, heart valve disease, mitral regurgitation, cardiovascular disease, mitral insufficiency

Brief summary

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

Interventions

DEVICEMedtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

mitral valve replacement

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Cohort	1 year	Composite of all-cause mortality or heart failure hospitalization
MAC Cohort	1 year	All-cause mortality

Secondary

Measure	Time frame	Description
All-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding	30 days or hospital discharge (whichever is later)	Composite
Degree of mitral regurgitation	6 months	measured by echocardiography
Quality of Life Improvement	3 months (KCCQ)	measured by KCCQ
Change in New York Heart Association Class	30 days	change in NYHA Class
Echocardiographic assessments of degree mitral valve regurgitation	1 year	measured by echocardiography
Cardiovascular hospitalizations	1 year	cardiovascular hospitalizations

Countries

Canada, Denmark, United States

Contacts

CONTACTMegan Wilder Fredrickson

rs.tmvrpivotaltrial@medtronic.com612-469-1749

STUDY_CHAIRMichael Mack, MD

Baylor Scott & White Hospital

PRINCIPAL_INVESTIGATORDavid Adams, MD

Icahn School of Medicine at Mount Sinai

PRINCIPAL_INVESTIGATORMartin Leon, MD

New York Presbyterian Hospital/Columbia University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026