Transcatheter Mitral Valve Replacement for Mitral Valve Regurgitation

Recruiting at 24 trial locations

Overseen By Sarah Brown

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiovascular

Disqualifiers: Prior valve surgery, Stroke, Myocardial infarction, Renal insufficiency, others

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

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

33 Participants Needed

Trial Summary

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 Twelve TMVR Implant for mitral valve regurgitation?

The treatment, known as transcatheter mitral valve replacement (TMVR), has shown potential in treating severe mitral regurgitation, with some early studies indicating feasibility and successful use in patients with other valve issues. However, the experience is limited, and there are high risks involved, suggesting the need for further research and improvements. ^{1 2 3 4 5}

Is transcatheter mitral valve replacement (TMVR) generally safe for humans?

TMVR is considered a feasible option for high-risk patients with severe mitral regurgitation, but its safety needs more evaluation through randomized controlled trials to understand risks like procedural invasiveness and valve deterioration. ^{6 7 8 9 10}

How is the Twelve TMVR Implant treatment different from other treatments for mitral valve regurgitation?

The Twelve TMVR Implant is a unique treatment for mitral valve regurgitation because it is a transcatheter mitral valve replacement (TMVR) that offers a less invasive alternative to open-heart surgery, using either transseptal or transapical routes to deliver the device. This approach is particularly beneficial for high-risk patients who may not be suitable candidates for traditional surgery. ^{1 2 3 5 11}

What is the purpose of this trial?

This trial tests new devices that replace a leaky heart valve without major surgery. It targets high-risk patients who can't undergo traditional surgery. The devices are inserted through a small tube to fix the valve.

Research Team

Lynnett Stahl

Principal Investigator

Medtronic

Eligibility Criteria

This trial is for very high-risk patients with severe, symptomatic mitral valve regurgitation (MR Grade 3-4+), specifically those who can undergo a transcatheter procedure. Participants must have a heart structure that fits the TMVR system and not have had recent strokes, heart attacks, or other valve surgeries.

Inclusion Criteria

Your doctor thinks it's possible to access your heart through the chest (for PILOT study only).

I have severe leakage in my heart's mitral valve.

Your mitral valve is the right shape and size for the Twelve TMVR/Intrepid device.

Exclusion Criteria

My kidney function is impaired with high creatinine levels.

There is something abnormal in your heart that could cause a blockage.

I have had or need surgery for a heart valve problem.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Transcatheter Mitral Valve Replacement (TMVR) implant

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

• Twelve TMVR Implant

Trial Overview The study tests two versions of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System: one via trans-apical access (PILOT) and another through transfemoral transseptal access (EFS). It aims to assess their safety and performance in treating severe mitral regurgitation.

Participant Groups

Group I: Transcatheter Mitral Valve Replacement (TMVR) Implant Experimental Treatment 2 Interventions

Twelve TMVR Implant

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

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Findings from Research

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]

In a study of five high-risk patients undergoing transcatheter mitral valve replacement (TMVR) with the Tendyne device, most patients showed significant improvement in symptoms and exercise capacity after 18 months to two years, indicating the device's efficacy.

Despite some complications, the Tendyne device demonstrated stability and good hemodynamic function, with no new paravalvular leaks or late migration observed in surviving patients, suggesting a favorable safety profile for this novel treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve replacement: long-term outcomes of first-in-man experience with an apically tethered device- a case series from a single centre. Duncan, A., Daqa, A., Yeh, J., et al.[2022]

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]

In a study of the first 100 patients undergoing transcatheter mitral valve replacement (TMVR), the procedure demonstrated a high technical success rate of 96% and an acceptable safety profile, with no intraprocedural deaths and only one major complication.

At one year post-procedure, 72.4% of patients were alive, with significant improvements in heart function and quality of life, as evidenced by 88.5% of survivors achieving New York Heart Association class I/II status and notable enhancements in walking distance and cardiomyopathy questionnaire scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients. Sorajja, P., Moat, N., Badhwar, V., 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]

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]

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]

Transcatheter mitral valve repair (TMVR) is a safer option than surgical mitral valve repair (SMVR) for older patients and those with more comorbidities, showing lower rates of complications such as permanent pacemaker implantation and major bleeding.

Despite being older and having higher comorbidity scores, TMVR patients experienced shorter hospital stays and were less likely to be discharged to skilled nursing facilities compared to those undergoing SMVR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of age and comorbidities on the effect of transcatheter versus surgical mitral valve repair on inpatient outcomes. Jogu, HR., Arora, S., Strassle, PD., et al.[2021]

Transcatheter mitral valve repair (TMVR) using the MitraClip system was successfully performed on 3 Chinese patients with severe mitral regurgitation, showing significant improvements in heart function and pressure measurements post-procedure.

All patients experienced a reduction in heart chamber sizes and NT-ProBNP levels, indicating improved heart function, with no complications reported, suggesting that TMVR is a safe and effective treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Initial experience of treating patients with severe mitral regurgitation with transcatheter mitral valve edge-to-edge repair in China]. Ge, JB., Zhou, DX., Pan, WZ., et al.[2013]

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]

References

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

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

2. France pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve replacement: long-term outcomes of first-in-man experience with an apically tethered device- a case series from a single centre. [2022]

3. France pubmed.ncbi.nlm.nih.gov

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

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

Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients. [2020]

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

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

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

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

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

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

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

Impact of age and comorbidities on the effect of transcatheter versus surgical mitral valve repair on inpatient outcomes. [2021]

9. China pubmed.ncbi.nlm.nih.gov

[Initial experience of treating patients with severe mitral regurgitation with transcatheter mitral valve edge-to-edge repair in China]. [2013]

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

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

11. Germany pubmed.ncbi.nlm.nih.gov

Early results of a real-world series with two transapical transcatheter mitral valve replacement devices. [2021]