33 Participants Needed

Transcatheter Mitral Valve Replacement for Mitral Valve Regurgitation

Recruiting at 24 trial locations
SB
Overseen BySarah Brown
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medtronic Cardiovascular
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.123511

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

LS

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.
See 2 more

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.
See 5 more

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
1Treatment groups
Experimental Treatment
Group I: Transcatheter Mitral Valve Replacement (TMVR) ImplantExperimental Treatment2 Interventions
Twelve TMVR Implant

Find a Clinic Near You

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 profile image

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz profile image

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

References

Early Experience With New Transcatheter Mitral Valve Replacement. [2022]
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]
Clinical outcomes of transcatheter mitral valve replacement: two-year results of the CHOICE-MI Registry. [2023]
Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients. [2020]
Transcatheter Mitral Valve Replacement for Native and Failed Bioprosthetic Mitral Valves. [2019]
Randomized Trials Are Needed for Transcatheter Mitral Valve Replacement. [2021]
Transcatheter mitral valve replacement with Mi-thos system: First-in-human experience. [2023]
Impact of age and comorbidities on the effect of transcatheter versus surgical mitral valve repair on inpatient outcomes. [2021]
[Initial experience of treating patients with severe mitral regurgitation with transcatheter mitral valve edge-to-edge repair in China]. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation. [2022]
Early results of a real-world series with two transapical transcatheter mitral valve replacement devices. [2021]
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