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Transcatheter Mitral Valve Replacement System

TMVR for Mitral Valve Regurgitation (APOLLO Trial)

N/A
Recruiting
Led By David Adams, MD
Research Sponsored by Medtronic Cardiovascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderate to severe or severe symptomatic mitral regurgitation
Be older than 18 years old
Must not have
Prohibitive mitral annular calcification
Hemodynamic instability
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new medical device. Everyone enrolled in the trial will receive the device.

Who is the study for?
This trial is for patients with severe symptoms of mitral valve regurgitation, who are considered unsuitable for standard treatments by a heart team. Candidates should not have had previous transcatheter mitral procedures, significant heart valve calcification, very weak heart pumping function (ejection fraction <30%), or be in need of urgent surgery.
What is being tested?
The trial is testing the Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) on all enrolled subjects. It's a global study that's prospective and non-randomized, meaning everyone gets the new device without being compared to another group.
What are the potential side effects?
While specific side effects aren't listed here, TMVR procedures can generally include risks like bleeding, infection at the catheter insertion site, damage to the blood vessels or heart from the device, irregular heartbeats, stroke or kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have moderate to severe symptoms from a leaky heart valve.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe calcium buildup on my heart's mitral valve.
Select...
My blood pressure and heart rate are stable.
Select...
My heart's pumping ability is very low.
Select...
I need surgery as soon as possible.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MAC Cohort
Primary Cohort
Secondary study objectives
Cardiovascular hospitalizations
Change in New York Heart Association Class
Echocardiographic assessments of degree mitral valve regurgitation
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Primary Cohort- TMVRExperimental Treatment1 Intervention
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Group II: Mitral Annular Calcification -TMVRExperimental Treatment1 Intervention
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)

Find a Location

Who is running the clinical trial?

Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
35,117 Total Patients Enrolled
Michael Mack, MDStudy ChairBaylor Scott & White Hospital
5 Previous Clinical Trials
1,466 Total Patients Enrolled
David Adams, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
572 Total Patients Enrolled

Media Library

Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) (Transcatheter Mitral Valve Replacement System) Clinical Trial Eligibility Overview. Trial Name: NCT03242642 — N/A
Mitral Valve Regurgitation Research Study Groups: Primary Cohort- TMVR, Mitral Annular Calcification -TMVR
Mitral Valve Regurgitation Clinical Trial 2023: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) Highlights & Side Effects. Trial Name: NCT03242642 — N/A
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) (Transcatheter Mitral Valve Replacement System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03242642 — N/A
~225 spots leftby Oct 2026
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