CardioMech MVRS for Mitral Valve Regurgitation

Not currently recruiting at 10 trial locations

Overseen By Danielle Dusenberry

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CardioMech AS

Disqualifiers: Rheumatic heart disease, Prior endocarditis, Others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Not specified

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the CardioMech Mitral Valve Repair System (MVRS) to evaluate its safety and effectiveness in treating mitral valve regurgitation. This condition occurs when the heart's mitral valve fails to close properly, causing blood to flow backward in the heart. The trial targets individuals diagnosed with moderate to severe mitral valve regurgitation due to a valve issue and who face risks with traditional surgery. Those informed by a doctor about these heart issues and the associated surgical risks might find this trial suitable. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for those unable to undergo traditional surgery.

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 CardioMech Mitral Valve Repair System is safe for patients with degenerative mitral valve regurgitation?

The CardioMech Mitral Valve Repair System (MVRS) aims to assist individuals with mitral valve regurgitation, a condition where the heart valve fails to close properly, causing blood to leak backward. Research has shown that patients generally tolerate the procedure well. No major reports have linked serious side effects directly to the CardioMech MVRS.

Although specific data from these studies is not provided here, it is important to note that the treatment is still under evaluation for safety and effectiveness. Ongoing research suggests that earlier results were promising enough to warrant further study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CardioMech Mitral Valve Repair System (MVRS) because it offers a minimally invasive approach to treating mitral valve regurgitation, a condition where the heart's mitral valve doesn't close tightly. Unlike traditional surgical options, which often involve open-heart surgery, the CardioMech MVRS is designed to be delivered through a catheter, reducing the need for large incisions and potentially leading to quicker recovery times. This innovative approach targets the mitral valve directly, aiming to restore its function without the extensive surgery typically required. This could mean a significant advancement in patient comfort and recovery, making it a promising alternative to current mitral valve repair techniques.

What evidence suggests that the CardioMech MVRS is effective for mitral valve regurgitation?

Research shows that the CardioMech Mitral Valve Repair System (MVRS) is designed to assist individuals with mitral valve regurgitation, a condition where the heart's mitral valve fails to close properly, causing blood to flow backward. Studies have found that repair systems using a thin tube, like CardioMech, effectively reduce symptoms in patients with moderate to severe cases. Early experiences with similar technologies suggest they can improve heart function and reduce the need for open-heart surgery. While specific data for CardioMech MVRS in humans is still being collected, its design aims to offer a less invasive option with promising early results. ^{1 3 5 6 7}

Who Is on the Research Team?

Mathew Williams, MD

Principal Investigator

NYU Langone

Mayra Guerrero, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with moderate to severe mitral valve regurgitation due to prolapse or flail, who are at intermediate or high risk for surgical repair. It's not suitable for those with a history of heart infections, previous mitral valve surgeries, rheumatic heart disease, severely calcified leaflets that prevent device placement, or complex MR mechanisms.

Inclusion Criteria

I am at a moderate to high risk for complications from mitral valve surgery.

My heart valve leaks severely due to a prolapse or flail.

Exclusion Criteria

Your mitral valve has too much calcium buildup, making it difficult for the device to be positioned and placed properly.

I have had surgery on my heart's mitral valve or a device installed in my heart.

I have had rheumatic heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CardioMech Mitral Valve Repair System (MVRS) for mitral valve repair

Not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CardioMech MVRS

Trial Overview The CardioMech Mitral Valve Repair System (MVRS) is being tested in this trial. The MVRS aims to safely and effectively treat degenerative mitral valve regurgitation without the need for traditional surgery.

How Is the Trial Designed?

Group I: CardioMech Mitral Valve Repair System (MVRS) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

CardioMech AS

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

Transcatheter mitral valve repair (TMVR) using MitraClip is safe and effective for patients with severe mitral regurgitation (MR), regardless of the underlying cause, based on a study of 558 patients over one year.

The study identified key predictors of outcomes after TMVR, including functional class, previous surgical revascularization, EuroSCORE II, diabetes mellitus, and left ventricular ejection fraction, which can help assess patient prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter mitral repair according to the cause of mitral regurgitation: real-life data from the Spanish MitraClip registry. Pascual, I., Arzamendi, D., Carrasco-Chinchilla, F., et al.[2021]

The PASCAL system for percutaneous mitral valve repair demonstrated a high technical success rate of 90% in 41 patients with severe mitral regurgitation, with 97% of patients maintaining a low MR grade (≤2) at an average follow-up of 8.7 months.

The procedure was found to be safe, with a low rate of major adverse events (3%) and significant improvements in patients' functional class and heart health markers, indicating its efficacy in treating severe mitral regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PASCAL-based mitral valve repair in an all-comer population: acute and mid-term clinical results. Schlegel, P., Crespo López, P., Kreusser, MM., et al.[2021]

The PASCAL system effectively treated severe mitral regurgitation (MR) in 92 patients, achieving a high overall success rate of 97.8%, with significant improvements in MR severity and patient quality of life at follow-up.

Patients experienced notable reductions in proBNP levels and pulmonary capillary wedge pressure, indicating improved heart function, with a low major adverse event rate of only 1.2% cardiovascular death at 30 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional and hemodynamic results after transcatheter mitral valve leaflet repair with the PASCAL device depending on etiology in a real-world cohort. Barth, S., Shalla, A., Kikec, J., et al.[2022]

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]

Mitral valve repair (MVR) for mitral regurgitation (MR) shows promising outcomes, with 75.2% of patients achieving excellent results post-surgery, but factors like ischemic etiology, low ejection fraction (EF), and urgent operations significantly increase the risk of mortality and poor long-term survival.

The study identified that not using a ring and Key's annuloplasty during the procedure are independent predictors for the need for reoperation, highlighting the importance of these techniques in improving both short-term and long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mitral valve repair for mitral regurgitation--15 year results]. Baev, B., Petkov, D., Iliev, R., et al.[2014]

Transcatheter mitral valve replacement (TMVR) shows promise but is currently limited by complications such as left ventricle outflow tract obstruction and major bleeding from the transapical approach, which is the most common method used.

Recent observational studies indicate that TMVR can be performed with acceptable safety and efficacy, suggesting that with improved device design and delivery systems, its adoption in clinical practice could increase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of adverse outcomes after transcatheter mitral valve replacement. Overtchouk, P., Piazza, N., Granada, JF., et al.[2019]

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]

A novel technique for transcatheter mitral valve replacement (TMVR) was successfully performed on three high-risk patients, involving the perforation and ballooning of the anterior mitral leaflet to prevent left ventricular outflow tract (LVOT) obstruction, achieving a 100% procedural success rate.

Intraoperative assessments showed no significant LVOT obstruction, indicating that this method may enhance the safety and efficacy of TMVR in patients who are not candidates for traditional surgical approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balloon assisted translocation of the mitral anterior leaflet to prevent left ventricular outflow obstruction (BATMAN): A novel technique for patients undergoing transcatheter mitral valve replacement. Helmy, T., Hui, DS., Smart, S., et al.[2020]

Transcatheter mitral valve repair and replacement (TMVR) offers a minimally invasive and safer alternative to traditional open-heart surgery for patients with mitral valve regurgitation, leading to better clinical outcomes.

TMVR has been associated with shorter hospital stays and lower mortality rates, highlighting its potential benefits, especially in regions like South Asia where heart-related complications are prevalent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement: An Alternate Treatment Methodology for Patients at High Surgical Risk. Jawed, S., Zubair, U., Zubair, Z.[2020]

In a study of 215 patients treated with the MitraClip™ device for severe mitral regurgitation, 6 patients required surgical re-intervention due to failed repair or recurrent MR, highlighting the potential complications of trans-catheter MVR.

While secondary surgical mitral valve repair was feasible for some patients after MitraClip™ treatment, others required valve replacement due to damage from the initial procedure, suggesting that careful patient selection is crucial to avoid complications in future surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of MitraClip™ therapy on secondary mitral valve surgery in patients at high surgical risk. Conradi, L., Treede, H., Franzen, O., et al.[2022]

In a study of 86 patients undergoing mitral valve repair, intraoperative transoesophageal echocardiography (TOE) was found to be the most sensitive method for detecting residual mitral regurgitation, identifying successful repairs in 87% of cases.

Despite saline testing indicating successful repairs, TOE revealed significant residual regurgitation in 8.2% of patients, leading to necessary interventions such as valve replacement or revision, highlighting the importance of accurate intraoperative imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of mitral valve repair by intraoperative transoesophageal echocardiography. Kalman, JM., Jones, EF., Lubicz, S., et al.[2019]

Current technologies for mitral valve repair and replacement include mechanical and bioprosthetic valves, each with specific advantages and limitations in surgical applications.

Emerging techniques such as neo-chordae fabrication and catheter-based repairs show promise in improving mitral valve interventions, although they come with their own set of challenges and limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging trends in heart valve engineering: Part III. Novel technologies for mitral valve repair and replacement. Kheradvar, A., Groves, EM., Simmons, CA., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04820764

NCT04820764 | EFS of the CardioMech MVRS The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe ...

2. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/mitral-valve-regurgitation

Mitral Valve Regurgitation Clinical Trials The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10272602/

A review of the development of interventional devices for ... A study of 449 patients who underwent mitral valve surgery from January 1995 to December 1999 showed that the operative mortality rate was 4.4%.

4. atriumhealth.org atriumhealth.org/dailydose/2021/12/01/first-in-world-procedure-repairs-leaky-heart-valve

First-in-World Procedure Repairs Leaky Heart Valve with ... CardioMech is developing a catheter-based mitral valve repair technology designed to treat patients suffering from moderate to severe or severe, symptomatic ...

5. clinconnect.io clinconnect.io/trials/NCT04820764

EFS of the CardioMech MVRS (NCT04820764) - ClinConnect Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.

6. mayo.edu mayo.edu/research/clinical-trials/cls-20516800

Early Feasibility Study of the CardioMech Mitral Valve ... The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe ...

7. trialx.com trialx.com/clinical-trials/listings/284261/efs-of-the-cardiomech-mvrs/?&geo_lat=40.7855&geo_lng=-73.845&radius=10&place=College%20Point&user_country=United%20States

EFS of the CardioMech MVRS | Clinical Research Trial ... Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.