AMEND Trans-Septal System for Mitral Regurgitation

Not yet recruiting at 1 trial location

Overseen By Madhuri Bhat

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Valcare Medical Ltd.

Must be taking: Heart failure medications

Must not be taking: Anti-platelets, Anti-coagulants

Disqualifiers: Endocarditis, Infection, Coronary disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the AMEND Trans-Septal System, designed to assist individuals with mitral regurgitation, a condition where the heart's mitral valve fails to close properly. The device, a special ring, can be placed in the heart without open surgery, providing a safer option for those at high risk for traditional surgery. The trial aims to determine if the device is safe and effective in reducing mitral regurgitation symptoms. Individuals with significant symptoms from mitral regurgitation and high surgical risk due to other health issues might be suitable candidates for this trial. As an unphased trial, it offers patients access to innovative treatment options that might not be available elsewhere.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must have been stable on your heart failure medications for at least one month before joining the study.

What prior data suggests that the AMEND Trans-Septal System is safe for treating mitral regurgitation?

A previous study found the AMEND Trans-Septal System to be safe and successful in procedures. This treatment uses a special ring placed in the heart to correct mitral regurgitation, a condition where the heart valve doesn't close properly. The system poses less risk than open-heart surgery, making it a suitable option for those unable to undergo surgery due to other health issues. So far, the device has demonstrated positive results and is considered safe for use in patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The AMEND™ Trans-Septal System is unique because it offers a novel approach to treating mitral regurgitation by providing a minimally invasive annuloplasty technique. Traditional treatments for this condition often include open-heart surgery or medication management, but the AMEND system is designed to reduce the need for invasive surgery. Researchers are excited because this system could improve safety and functionality for patients, offering a less invasive alternative with potentially quicker recovery times. By targeting the root structure of the mitral valve through a trans-septal approach, it may also provide more precise and effective results compared to existing methods.

What evidence suggests that the AMEND Trans-Septal System is effective for mitral regurgitation?

Research has shown that the AMEND Trans-Septal System could be a promising treatment for mitral regurgitation, a heart valve problem. The system is considered safe and effective during the procedure. Studies indicate that patients experience significant improvements in their daily lives after the treatment. After one year, 87% of patients remained alive, 66% did not require hospitalization for heart failure, and 78% did not need additional procedures. These results suggest that the AMEND Trans-Septal System could be a dependable option for individuals with mitral valve issues. Participants in this trial will join a prospective, single-arm, open trial to evaluate the safety and functionality of the AMEND Trans-Septal System for MR reduction. ^{1 2 3 5 6}

Who Is on the Research Team?

Dr. David Meerkin, CMO, MD

Principal Investigator

Valcare Medical

Are You a Good Fit for This Trial?

This trial is for adult men and women with mitral insufficiency, which is a type of heart valve leak. It's especially aimed at those who are high-risk surgical candidates due to other health issues or age. The AMEND™ Trans-Septal System may be used alone or with other treatments.

Inclusion Criteria

LV Ejection Fraction > 30%, LVEDD < 68 mm

Subject is at high risk for mitral valve surgery as assessed by the center's heart team for mitral procedures

Femoral vein access and transseptal device access is determined to be feasible by the implanting investigator

Exclusion Criteria

Life expectancy of less than 12 months

Previously implanted prosthetic aortic valve or mitral intervention

Known allergy to nickel

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the AMEND Trans-Septal System implant for mitral regurgitation treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Multiple visits (in-person and virtual)

Extended Follow-up

Participants are monitored for long-term safety and effectiveness

6 months to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• AMEND™ Trans-Septal System

Trial Overview The study tests the AMEND™ Trans-Septal System, a semi-rigid annuloplasty ring delivered through a catheter to repair the mitral valve without open-heart surgery. This early feasibility study evaluates its safety and functionality in patients.

How Is the Trial Designed?

Group I: prospective, single arm, open trial to evaluate the safety, functionality of the AMEND TS System Experimental Treatment 1 Intervention

The AMEND TS EFS is a prospective, single arm, open clinical trial designed to evaluate the safety and functionality of the AMENDTM Trans-Septal System for MR reduction in patients suffering from functional mitral regurgitation. This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.

Who Is Running the Clinical Trial?

Valcare Medical Ltd.

Lead Sponsor

Trials

1

Recruited

4+

Published Research Related to This Trial

The CHAGALL trial demonstrated that a novel automated chordal system for implanting artificial mitral chords was technically successful in all 5 patients with severe mitral regurgitation, showing no or trace residual MR after 12 months.

There were no device-related complications, and all patients survived the initial 30 days, indicating the safety and efficacy of this new approach for mitral valve repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Implantation of Artificial Mitral Chords: Preliminary Results From the Feasibility Trial. Weber, A., Rucinskas, K., Janusauskas, V., et al.[2020]

The MitraClip Transcatheter Mitral Valve Repair system has been shown to be safe and effective for treating symptomatic degenerative mitral regurgitation in high-risk patients, with over 4,000 patients treated in the U.S. and more than 35,000 worldwide since its approval in 2013.

Real-world data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry indicate that the MitraClip may be even safer and more effective than results from initial clinical trials, highlighting its potential for broader use in various patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Repair of Mitral Regurgitation. Barker, CM.[2019]

The PASCAL transcatheter valve repair system achieved a high procedural success rate of 96.9% in treating mitral regurgitation under conscious sedation in a study of 211 patients, indicating its efficacy as a treatment option.

The procedure resulted in significant improvements in mitral regurgitation and functional class, with a low mortality rate of 2.8% and a short hospital stay, suggesting it is a safe and efficient alternative to general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of patients undergoing edge-to-edge mitral valve repair with the Edwards PASCAL transcatheter valve repair system under conscious sedation. Geisler, T., Schreieck, J., Euper, M., et al.[2023]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jcin.2024.11.042

Transseptal Mitral Annuloplasty With the AMEND System In this report, the AMEND transseptal mitral annuloplasty system is safe, has a high procedural success rate, and results in significant AP ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.068847

Contemporary Outcomes and Trends for the Transseptal ... This multicenter, prospective study reports excellent procedural outcomes, acceptable 1-year mortality rates, and a significant improvement in quality of life

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7867416/

Transseptal direct complete annuloplasty: early experience At one year, overall survival, survival free of readmission for heart failure, and survival free of reintervention were 87%, 66% and 78% respectively. Mitral ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666084925015190

Transseptal Transcatheter Mitral Valve Replacement With ... At 30-day follow-up, the patient had sustained elimination of MR and favorable bioprosthetic valve function (mean transmitral gradient 4.3 mm Hg ...

5. valcaremedical.com valcaremedical.com/valcare-medical-receives-fda-approval-to-initiate-early-feasibility-study-for-its-novel-amend-trans-septal-system/

Valcare Medical Receives FDA Approval to Initiate Early ... The EFS study will evaluate the safety and functionality of the AMEND™ Trans-Septal System in the treatment of subjects with symptomatic ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1936879823012682

1-Year Outcomes Following Transfemoral Transseptal ... The 1-year results from the HighLife TSMVR feasibility study demonstrate a high technical success rate, excellent valve function, no left ventricular outflow ...