TMVR for Mitral Valve Regurgitation

(APOLLO Trial)

Recruiting at 94 trial locations

Overseen By Megan Wilder Fredrickson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiovascular

Disqualifiers: Prior mitral procedure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Hospital stay (up to 30 days or until discharge)

1056 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with mitral valve regurgitation, a condition where the heart's mitral valve doesn't close tightly, causing blood to flow backward. The trial uses the Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) to determine its effectiveness for those with significant symptoms. It seeks participants with moderate to severe symptoms who are not suitable candidates for other approved treatments or surgeries. As an unphased trial, this study provides a unique opportunity to access innovative treatment options not yet widely available.

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 prior data suggests that the Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) is safe for treating mitral valve regurgitation?

Research has shown that the Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) appears safe so far. Early studies found that the valve functions well, with no deaths or strokes reported shortly after the procedure. In one early study involving 15 patients, all survived and experienced no strokes 30 days post-procedure.

These findings are encouraging signs of safety. However, while these early results are promising, more detailed long-term data is still being collected. Prospective trial participants should discuss these findings with their doctor to make an informed decision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) is unique because it offers a minimally invasive alternative for treating mitral valve regurgitation, a condition often addressed by open-heart surgery. Unlike traditional surgical methods, TMVR can be delivered via a catheter, reducing the need for a large chest incision and potentially leading to quicker recovery times. Researchers are excited about TMVR because it provides an option for patients who are too high-risk for surgery, expanding treatment possibilities for those who previously had limited options.

What evidence suggests that the Medtronic Intrepid TMVR System is effective for mitral valve regurgitation?

Research has shown that the Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) holds promise for treating mitral valve regurgitation, a condition where the heart's mitral valve doesn't close tightly. This trial will evaluate the effectiveness of the Intrepid TMVR in two separate cohorts. Studies have found that this system effectively reduces symptoms in most patients. In one study with 50 patients, the procedure succeeded 98% of the time, and most patients experienced little to no remaining valve leakage. Additionally, an early study found the valve performed well, with no deaths or strokes within 30 days after the procedure. These results suggest that the Intrepid TMVR could be a good option for people with mitral valve problems. ^{1 4 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

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.

How Is the Trial Designed?

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)

Who Is Running the Clinical Trial?

Medtronic Cardiovascular

Lead Sponsor

Trials

78

Recruited

37,300+

Geoff Martha

Medtronic Cardiovascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Kendra J. Grubb

Medtronic Cardiovascular

Chief Medical Officer

MD from Emory University

Published Research Related to This Trial

Transcatheter mitral valve replacement (TMVR) using a new self-expanding valve was successfully performed in 50 high-risk patients with symptomatic severe mitral regurgitation, achieving a high device implant success rate of 96%.

At a median follow-up of 173 days, 79% of patients showed significant improvement in their symptoms, with mild or no residual mitral regurgitation confirmed by echocardiography, indicating the procedure's efficacy in enhancing patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Transcatheter mitral valve replacement (TMVR) in high-surgical-risk patients with severe mitral regurgitation showed significant improvements, with 93.2% of surviving patients having no mitral regurgitation at 2 years and a reduction in heart failure hospitalizations from 1.30 to 0.51 events per year post-procedure.

While the all-cause mortality rate was 39% over 2 years, with a notable 43.6% of deaths occurring within the first 90 days, the procedure led to sustained symptom improvement, with 81.6% of patients reporting NYHA functional class I or II at 2 years.

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]

In a study of 33 high-risk patients with moderate to severe mitral regurgitation, the Intrepid transcatheter mitral valve replacement (TMVR) showed a high success rate of 93.9% for valve implantation, with no deaths or strokes reported at 30 days post-procedure.

At 1 year, the TMVR demonstrated a low all-cause mortality rate of 6.7%, significant improvement in heart function, and near complete elimination of mitral regurgitation, indicating both safety and efficacy of this novel treatment approach.

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]

Transcatheter mitral valve replacement (TMVR) offers a promising solution for completely eliminating mitral regurgitation (MR), which is a significant advantage over less certain transcatheter repair methods like TEER.

The authors emphasize the importance of conducting randomized controlled trials (RCTs) to thoroughly evaluate the safety and effectiveness of TMVR compared to existing treatments, as well as to inform clinical practices and reimbursement policies.

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]

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]

Transcatheter mitral valve replacement (TMVR) is a new treatment for severe mitral regurgitation, but it currently has a high 30-day mortality rate exceeding 30%, indicating significant risks associated with the procedure.

Despite its challenges, TMVR has shown promise in treating patients with degenerative mitral stenosis and failed mitral repairs, leading to ongoing multicenter registries aimed at improving device design and understanding the procedure's effectiveness.

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]

The Mi-thos TMVR system was successfully implanted in all 10 high-risk patients with severe mitral regurgitation, demonstrating a 100% intraoperative success rate without any periprocedural mortality or major complications during the 30-day follow-up.

All patients showed no or trace mitral regurgitation after the procedure, indicating effective valve function, with a median mitral valve gradient of 2.0 mmHg, suggesting that the Mi-thos TMVR system is a safe and feasible option for this patient population.

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]

The Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System is being evaluated for its efficacy in treating mitral regurgitation, a common but often untreated heart valve condition, in a randomized trial against traditional surgical valve replacement.

There is optimism that transcatheter mitral interventions could significantly change how severe symptomatic mitral regurgitation is managed, despite existing challenges in integrating these new treatments into standard care.

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]

In a study of 400 high-risk patients with symptomatic mitral regurgitation undergoing transcatheter mitral valve replacement (TMVR), the procedure achieved a technical success rate of 95.2% and resulted in significant improvements in heart function over 2 years.

Despite the high success rate, the 2-year all-cause mortality rate was 38.1%, with chronic obstructive pulmonary disease and other health factors identified as predictors of mortality, highlighting the need for careful patient selection and management to enhance outcomes.

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03242642

Study Details | NCT03242642 | Transcatheter Mitral Valve ... Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device. Official Title.

2. eurointervention.pcronline.com eurointervention.pcronline.com/article/intrepid-transcatheter-mitral-valve-replacement-system-technical-and-product-description

Intrepid transcatheter mitral valve replacement system Treatment of mitral regurgitation by transcatheter mitral valve replacement (TMVR) is feasible with over a hundred completed procedures worldwide.

3. jacc.org jacc.org/doi/10.1016/j.jcin.2021.10.018

Intrepid TMVR Early Feasibility Study Results Thirty-day results from the Intrepid transfemoral TMVR early feasibility study demonstrate excellent valve function and no mortality or stroke.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6288225/

Early experience with the Intrepid system for transcatheter ... The Intrepid prosthesis has been found to be effective for relief of mitral regurgitation and associated with functional improvement in the majority of ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.125.015298

TMVR for the Treatment of Mitral Regurgitation: A State-of- ... In the first pilot trial (50 patients), the 30-day mortality rate was 14%, with a procedural success rate of 98% and mild or no residual MR ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34747699/

Intrepid TMVR Early Feasibility Study Results Thirty-day results from the Intrepid transfemoral TMVR early feasibility study demonstrate excellent valve function and no mortality or stroke.

7. news.medtronic.com news.medtronic.com/2021-11-06-Medtronic-announces-early-data-for-the-Intrepid-TM-transcatheter-mitral-valve-replacement-TMVR-system-using-new-transfemoral-delivery-system

Medtronic announces early data for the Intrepid™ ... Data from the first 15 patients enrolled in an Early Feasibility Study of the Intrepid Transfemoral System showed 100% survival and no stroke.

8. medtronic.com medtronic.com/en-us/l/patients/clinical-trials/apollo/about.html

About the Trial - APOLLO Trial The APOLLO Trial is studying the safety and efficacy of an investigative device called the Intrepid™ transcatheter mitral valve replacement system. The ...