Cephea Valve System for Mitral Regurgitation

Recruiting at 20 trial locations

Overseen By Jennifer Studt

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Disqualifiers: Prior surgery, Emergent surgery, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-implant

50 Participants Needed

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.

How is the Cephea Mitral Valve System treatment different from other treatments for mitral regurgitation?

The Cephea Mitral Valve System is unique because it offers a transcatheter approach to replace the mitral valve, which is less invasive than traditional surgery. This system is designed to be inserted through a catheter, providing an option for patients who are at high risk for surgical procedures. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new device called the Cephea Mitral Valve System that can fix or replace a damaged heart valve using a thin tube. It aims to help patients with mitral valve disease who need a less invasive treatment than open-heart surgery. The Cephea Mitral Valve System is a new technology developed by Cephea Valve Technologies, aiming to treat severe mitral regurgitation through a less invasive approach.

Research Team

Barathi Sethuraman

Principal Investigator

Abbott Structural Heart

Eligibility Criteria

This trial is for patients with severe mitral valve regurgitation (a heart valve problem) who are symptomatic and have a left ventricular ejection fraction (LVEF) of at least 30%. It's aimed at those for whom a non-surgical, catheter-based approach is better than open-heart surgery. Patients who've had previous treatments that could affect the new valve can't participate.

Inclusion Criteria

LVEF ≥ 30%

I have severe mitral valve disease with significant regurgitation or narrowing.

My doctors recommend a less invasive heart procedure over open heart surgery.

Exclusion Criteria

I need surgery as soon as possible.

I've had surgery that affects heart valve replacement.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Cephea Mitral Valve System for the treatment of mitral valve disease

Immediate post-implant

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at 30 days post implant

Treatment Details

Interventions

• Cephea Mitral Valve System

Trial Overview The Cephea Mitral Valve System is being tested to see if it's safe and effective in treating severe mitral regurgitation without needing open-heart surgery. The study involves placing this device into the heart through a catheter to help control blood flow.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Findings from Research

The novel Cephea transcatheter mitral valve replacement system demonstrated excellent biological performance and safety in a preclinical model, with all 10 sheep surviving the study without complications and showing no signs of thrombosis or excessive calcification.

The transseptal delivery method was feasible and effective in pigs, with stable valve positioning and good hemodynamic profiles confirmed through echocardiography and autopsy, suggesting potential for future human applications in treating severe mitral regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental Evaluation of a Novel Percutaneous Transseptal Catheter-Based Mitral Valve Replacement Technology. Vahl, TP., Grogan, A., Cheng, Y., et al.[2020]

The MitraClip system offers a less invasive, catheter-based alternative for treating mitral valve regurgitation, which is the most common type of heart valve insufficiency, potentially benefiting a large patient population that currently avoids surgery due to high risks.

As the first commercially available technology for nonsurgical repair of mitral valve regurgitation, the MitraClip has the most clinical experience among similar devices and is currently undergoing late-stage clinical trials in the USA while already having received the CE mark in Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MitraClip catheter-based mitral valve repair system. Jönsson, A., Settergren, M.[2010]

The ChoRe device was successfully designed to place artificial chords in the mitral valve during a trans-catheter procedure, aiming to treat mitral valve regurgitation caused by chordae tendineae rupture.

In tests on bovine hearts, the ChoRe demonstrated the ability to securely fix artificial chords in an average time of about 3.45 minutes, indicating its potential for efficient use in future patient-specific treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ChoRe: A device for trans-catheter chordae tendineae repair. Culmone, C., Ali, A., Scali, M., et al.[2020]

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]

Functional mitral regurgitation is linked to poorer outcomes in patients with heart failure and those undergoing coronary artery bypass surgery, highlighting the need for effective treatment options.

Contemporary coronary sinus annuloplasty devices, such as the Edwards MONARC system and Cardiac Dimensions CARILLON, offer a less invasive alternative for patients with severe mitral regurgitation, potentially reducing complications associated with traditional mitral valve surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve repair for functional mitral regurgitation: coronary sinus approach. Piazza, N., Bonan, R.[2007]

References

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

Experimental Evaluation of a Novel Percutaneous Transseptal Catheter-Based Mitral Valve Replacement Technology. [2020]

2. England pubmed.ncbi.nlm.nih.gov

MitraClip catheter-based mitral valve repair system. [2010]

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

ChoRe: A device for trans-catheter chordae tendineae repair. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Transcatheter mitral valve repair for functional mitral regurgitation: coronary sinus approach. [2007]