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Transcatheter Mitral Valve Replacement System

TMVR for Mitral Valve Regurgitation (APOLLO Trial)

Q: How many people are participating in this experiment?

For this research trial to be successful, 1350 qualified participants must join. Medtronic <a href="https://www.withpower.com/clinical-trials/cardiovascular">Cardiovascular</a> is the project sponsor and will manage the proceedings from various points of service such as Mercy Medical Center in Des Moines, <a href="https://www.withpower.com/clinical-trials/iowa">Iowa</a> and NYU Winthrop Hospital in Mineola, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>.

Q: What are the objectives of this clinical investigation?

Over the course of a year, the primary outcome that will be assessed is <a href="https://www.withpower.com/clinical-trials/mac">MAC</a> Cohort. Secondary outcomes include <a href="https://www.withpower.com/clinical-trials/cardiovascular">Cardiovascular</a> hospitalizations, <a href="https://www.withpower.com/clinical-trials/all">all</a>-cause mortality, disabling <a href="https://www.withpower.com/clinical-trials/stroke">stroke</a>, acute kidney injury, prolonged ventilation and deep wound infection as well as reoperation or reintervention and major bleeding (Composite). Quality of Life Improvement will also be evaluated via SF-12 and KCCQ metrics.

Q: Are there any opportunities to participate in this trial currently available?

Clinicaltrials.gov informs us that this clinical trial, initiated on October 23rd 2017, is still accepting participants. The latest update was posted on August 5th 2022.

Q: Are there plentiful venues conducting this medical trial on a state level?

The trial is recruiting at 55 locations, including the cities of Des Moines, Mineola and Wynnewood. It is important to choose a site as nearby as possible in order to minimize travel obligations for participants.

N/A

Recruiting

Led By Martin Leon, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

APOLLO Trial 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.Check my eligibility

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.See study design

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.

APOLLO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have moderate to severe symptoms from a leaky heart valve.

APOLLO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MAC Cohort

Primary Cohort

Secondary outcome measures

Cardiovascular hospitalizations

Change in New York Heart Association Class

Echocardiographic assessments of degree mitral valve regurgitation

+2 more

APOLLO 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)

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medtronic CardiovascularLead Sponsor

75 Previous Clinical Trials

35,176 Total Patients Enrolled

Martin Leon, MDPrincipal InvestigatorNew York Presbyterian Hospital/Columbia University Medical Center

3 Previous Clinical Trials

1,301 Total Patients Enrolled

Michael Mack, MDStudy ChairBaylor Scott & White Hospital

5 Previous Clinical Trials

1,466 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are participating in this experiment?

"For this research trial to be successful, 1350 qualified participants must join. Medtronic Cardiovascular is the project sponsor and will manage the proceedings from various points of service such as Mercy Medical Center in Des Moines, Iowa and NYU Winthrop Hospital in Mineola, New york."

Answered by AI

What are the objectives of this clinical investigation?

"Over the course of a year, the primary outcome that will be assessed is MAC Cohort. Secondary outcomes include Cardiovascular hospitalizations, all-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation and deep wound infection as well as reoperation or reintervention and major bleeding (Composite). Quality of Life Improvement will also be evaluated via SF-12 and KCCQ metrics."

Answered by AI

Are there any opportunities to participate in this trial currently available?

"Clinicaltrials.gov informs us that this clinical trial, initiated on October 23rd 2017, is still accepting participants. The latest update was posted on August 5th 2022."

Answered by AI

Are there plentiful venues conducting this medical trial on a state level?

"The trial is recruiting at 55 locations, including the cities of Des Moines, Mineola and Wynnewood. It is important to choose a site as nearby as possible in order to minimize travel obligations for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03242642.

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