AMEND Trans-Septal System for Mitral Regurgitation

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

15 Participants Needed

Trial Summary

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 data supports the effectiveness of the AMEND Trans-Septal System treatment for mitral regurgitation?

The PASCAL transcatheter valve repair system, which is similar to the AMEND Trans-Septal System, has shown positive outcomes in treating mitral regurgitation, providing more treatment options and improving patient symptoms. Additionally, the Intrepid system, another transcatheter method, has been effective in relieving mitral regurgitation and improving function in patients. ^{1 2 3 4 5}

How is the AMEND Trans-Septal System treatment for mitral regurgitation different from other treatments?

The AMEND Trans-Septal System is unique because it is a transcatheter device specifically designed for mitral valve repair, offering a less invasive option compared to traditional surgery. Unlike other treatments, it focuses on trans-septal access, which may provide a novel approach to treating patients with high surgical risk. ^{4 6 7 8 9}

What is the purpose of this trial?

The purpose of this clinical investigation, the AMEND TS Early Feasibility Study is to evaluate the safety and functionality of the AMEND Trans-Septal System for annuloplasty as treatment of mitral regurgitation. Protocol Design Rationale The investigational device under this protocol consists of a "D"-shaped semi-rigid ring that is implanted using a transseptal approach. The ability to deploy the annuloplasty ring in a percutaneous fashion affords an improved safety profile for surgical candidates, as well as surgical style solution for those patients that are at elevated risk for surgery due to comorbidities and advanced age. This early feasibility study allows treatment of higher risk surgical candidates with a surgical- level annuloplasty repair therapy by the AMEND™ Implant. This clinical investigation is intended to evaluate the safety and functionality of the AMEND™ Trans-Septal System. Study results are expected to provide information that cannot be obtained through non-clinical testing, due to the limitations of in-vivo and in-vitro test models. The AMEND™ Trans-septal System has previously undergone extensive preclinical and bench testing as well as initial OUS clinical experience. The results of these tests and clinical data obtained so far, justify the use of the device in the EFS IDE study as proposed in this study protocol. DEVICE DESCRIPTION Valcare Medical AMENDTM Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation. It is designed to be used as standalone therapy or in combination with other repair treatments. The device is delivered through a catheter using a trans-septal approach and implanted in the beating heart on the atrial surface of the mitral valve annulus similar to surgical annuloplasty rings. The AMENDTM Trans-Septal System consists of a semi-rigid annuloplasty ring (implant), a delivery system (catheter), and accessories (Stage, Introducer sheath). The implant delivered under fluoroscopic and echocardiographic guidance, is placed and fixed to achieve an anatomic outcome that is consistent with standard open surgical annuloplasty procedures. The system is a single-use device, supplied sterile, non-pyrogenic and ready-for-use. Indications for Use The Valcare Medical AMEND™ Trans-Septal System is intended for correction of mitral insufficiency in adult male and female patients. It is indicated to treat patients with mitral regurgitation using a percutaneous direct annuloplasty approach. The decision to use an annuloplasty ring is made by the heart center team after reviewing the risks and benefits of alternative procedures and evaluating the patient's mitral valve disease.

Research Team

Dr. David Meerkin, CMO, MD

Principal Investigator

Valcare Medical

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Transcatheter Mitral Cerclage Ventriculoplasty: From Bench to Bedside. [2023]

2. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

One-Year Outcomes According to Mitral Regurgitation Etiology Following Transcatheter Edge-to-Edge Repair With the PASCAL System: Results From a Multicenter Registry. [2023]

4. China pubmed.ncbi.nlm.nih.gov

Early experience with the Intrepid system for transcatheter mitral valve replacement. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

PASCAL mitral valve repair system versus MitraClip: comparison of transcatheter edge-to-edge strategies in complex primary mitral regurgitation. [2022]

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

Transcatheter Mitral Valve Replacement with Dedicated Devices. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Automated Implantation of Artificial Mitral Chords: Preliminary Results From the Feasibility Trial. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Beating heart mitral valve repair with neochordae implantation: real-time monitoring of haemodynamic recovery. [2018]

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

Percutaneous Repair of Mitral Regurgitation. [2019]