TMVR for Mitral Valve Regurgitation

(APOLLO Trial)

Recruiting in Palo Alto (17 mi)

+90 other locations

Overseen by Martin Leon, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medtronic Cardiovascular

Disqualifiers: Prior mitral procedure, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) for Mitral Valve Regurgitation?

Early studies suggest that the Medtronic Intrepid TMVR System may be effective for patients with severe mitral regurgitation (a condition where the heart's mitral valve doesn't close tightly, allowing blood to flow backward in the heart) who are not good candidates for surgery. The system is being tested against traditional surgical methods, and there is optimism about its potential to improve treatment for this condition. ^{1 2 3 4 5}

Is the Intrepid TMVR system safe for humans?

The Intrepid TMVR system has been used in patients who are at high risk for traditional surgery, and early trials have been conducted to assess its safety. However, more studies are needed to fully understand the risks, including potential procedural invasiveness and long-term valve issues. ^{2 3 6 7 8}

How is the Medtronic Intrepid TMVR System treatment different from other treatments for mitral valve regurgitation?

The Medtronic Intrepid TMVR System is unique because it offers a minimally invasive option for high-risk patients with mitral valve regurgitation who are not suitable for traditional surgery, using a transcatheter approach that can be delivered through transfemoral transseptal access. ^{1 2 3 5 9}

Research Team

David Adams, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Martin Leon, MD

Principal Investigator

New York Presbyterian Hospital/Columbia University Medical Center

Michael Mack, MD

Principal Investigator

Baylor Scott & White Hospital

Eligibility Criteria

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.

Inclusion Criteria

A team of heart specialists agrees I can't have standard heart valve treatments.

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

Exclusion Criteria

My heart's pumping ability is very low.

I need surgery as soon as possible.

I have severe calcium buildup on my heart's mitral valve.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Medtronic Transcatheter Mitral Valve Replacement System (TMVR) for treatment of mitral regurgitation

Hospital stay (up to 30 days or until discharge)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of mortality, heart failure hospitalization, and echocardiographic evaluations

1 year

Quality of Life Assessment

Participants' quality of life is assessed using SF-12 and KCCQ

3 months

Treatment Details

Interventions

• Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) (Transcatheter Mitral Valve Replacement System)

Trial Overview 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.

Participant Groups

Group I: Primary Cohort- TMVR Experimental Treatment 1 Intervention

Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)

Group II: Mitral Annular Calcification -TMVR Experimental Treatment 1 Intervention

Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Morton Plant Clearwater, FL

NYU Langone Medical Center New York, NY

Saint Francis Hospital Roslyn, NY

Massachusetts General Hospital Boston, MA

More Trial Locations

Who Is Running the Clinical Trial?

Medtronic Cardiovascular

Lead Sponsor

Trials

78

Patients Recruited

37,300+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of transcatheter mitral valve replacement: two-year results of the CHOICE-MI Registry. Ludwig, S., Perrin, N., Coisne, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Experience With New Transcatheter Mitral Valve Replacement. Bapat, V., Rajagopal, V., Meduri, C., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation. Muller, DWM., Sorajja, P., Duncan, A., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Implantation with the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System. Koh, JQ., Walton, A., Marasco, S., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results. Zahr, F., Song, HK., Chadderdon, S., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve replacement with Mi-thos system: First-in-human experience. Yang, Y., Chen, J., Dong, L., et al.[2023]

Transcatheter mitral valve replacement using the Intrepid device is designed for patients at high risk for traditional surgery, offering a less invasive option for those needing mitral valve replacement.

The early results from the Apollo trial, which compares the Intrepid device to conventional surgery, highlight the unique challenges of mitral valve implants, indicating the need for careful consideration of the device's design and implantation procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement with Intrepid. McCarthy, PM., Kislitsina, ON., Malaisrie, SC., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trials Are Needed for Transcatheter Mitral Valve Replacement. Rogers, JH., Sorajja, P., Thourani, VH., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement for Native and Failed Bioprosthetic Mitral Valves. Sarkar, K., Reardon, MJ., Little, SH., et al.[2019]

References

1. France pubmed.ncbi.nlm.nih.gov

Clinical outcomes of transcatheter mitral valve replacement: two-year results of the CHOICE-MI Registry. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Early Experience With New Transcatheter Mitral Valve Replacement. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Implantation with the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve replacement with Mi-thos system: First-in-human experience. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement with Intrepid. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Randomized Trials Are Needed for Transcatheter Mitral Valve Replacement. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement for Native and Failed Bioprosthetic Mitral Valves. [2019]