CardioMech MVRS for Mitral Valve Regurgitation

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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called the CardioMech Mitral Valve Repair System (MVRS) to help patients with a leaky heart valve who are at high risk for surgery. The device aims to fix the valve and improve heart function without needing open-heart surgery. The HARPOON Beating Heart Mitral Valve Repair System (MVRS) has shown it can safely and effectively repair the heart valve while the heart is still beating.

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 CardioMech MVRS treatment for Mitral Valve Regurgitation?

While there is no direct data on the CardioMech MVRS, similar transcatheter mitral valve repair systems, like the Medtronic Intrepid™, show promise in addressing mitral regurgitation, suggesting potential effectiveness for CardioMech MVRS as well. ^{1 2 3 4 5}

Is the CardioMech MVRS safe for humans?

The safety of transcatheter mitral valve replacement (TMVR) systems, like the CardioMech MVRS, has been evaluated in various studies. Some risks include complications such as left ventricular outflow tract obstruction, device dislocation, and bleeding, but recent studies suggest that these systems have acceptable safety profiles for high-risk patients. ^{1 6 7 8 9}

How is the CardioMech MVRS treatment different from other treatments for mitral valve regurgitation?

The CardioMech MVRS is a minimally invasive treatment for mitral valve regurgitation that uses a catheter to repair the valve, offering a safer alternative to traditional open-heart surgery. This approach can lead to better outcomes, shorter hospital stays, and lower mortality rates, especially for patients at high surgical risk. ^{1 10 11 12 13}

Research Team

Mayra Guerrero, MD

Principal Investigator

Mayo Clinic

Mathew Williams, MD

Principal Investigator

NYU Langone

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

PASCAL-based mitral valve repair in an all-comer population: acute and mid-term clinical results. [2021]

2. Bulgaria pubmed.ncbi.nlm.nih.gov

[Mitral valve repair for mitral regurgitation--15 year results]. [2014]

3. Australia pubmed.ncbi.nlm.nih.gov

Evaluation of mitral valve repair by intraoperative transoesophageal echocardiography. [2019]

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

Emerging trends in heart valve engineering: Part III. Novel technologies for mitral valve repair and replacement. [2015]

6. 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]

7. United States 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. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Predictors of adverse outcomes after transcatheter mitral valve replacement. [2019]

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

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

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

Transcatheter Mitral Valve Replacement: An Alternate Treatment Methodology for Patients at High Surgical Risk. [2020]

11. Spain pubmed.ncbi.nlm.nih.gov

Transcatheter mitral repair according to the cause of mitral regurgitation: real-life data from the Spanish MitraClip registry. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

Impact of MitraClip™ therapy on secondary mitral valve surgery in patients at high surgical risk. [2022]

13. Netherlands 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. [2022]