Cephea Valve System for Mitral Regurgitation

Recruiting at 26 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Cephea Mitral Valve System to determine its safety and effectiveness for individuals with mitral valve problems. It targets those with symptoms from conditions like mitral regurgitation (a leaky valve) or mitral stenosis (a narrowed valve) who would benefit from a less invasive option than open-heart surgery. The trial seeks participants with significant mitral valve issues who are better suited for a transcatheter procedure, a less invasive method.

As an unphased trial, this study provides patients the opportunity to access innovative treatment options that might not be available elsewhere.

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 Cephea Mitral Valve System is safe for treating mitral valve disease?

Research has shown that the Cephea Mitral Valve System appears promising in terms of safety. In one study conducted at a single location, the system was successfully used in three patients. Although this number is small, it suggests the device is generally well-tolerated. Other studies are examining how using this system to fix mitral valve problems affects health outcomes. These studies are ongoing, and more information will help confirm its safety. If these studies find the treatment safe, it could offer a less invasive alternative to open-heart surgery, significantly benefiting many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Cephea Mitral Valve System is unique because it offers a less invasive way to treat mitral valve disease, including conditions like mitral regurgitation and stenosis. Unlike traditional surgical options that require open-heart surgery, this system can be delivered through a catheter, which means it could potentially result in a shorter recovery time and fewer complications. Researchers are excited about this treatment because it could improve the quality of life for patients who are not good candidates for surgery, providing them with a safer and more efficient alternative.

What evidence suggests that the Cephea Mitral Valve System is effective for mitral valve disease?

Research has shown that the Cephea Mitral Valve System, which participants in this trial will receive, holds promise for treating mitral valve disease. One study found the procedure successful in 96% of patients, with 94% experiencing positive results. Early use of this system also demonstrated a high success rate in several patients. These findings suggest that the Cephea system can effectively address mitral valve issues, potentially improving symptoms for those with conditions like a leaky valve. Overall, evidence indicates that this system is a strong option for individuals needing a less invasive procedure instead of open-heart surgery. ^{1 2 3 4 5}

Who Is on the Research Team?

Barathi Sethuraman

Principal Investigator

Abbott Structural Heart

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07069673

Abbott Cephea Mitral Valve Disease Registry Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05061004

NCT05061004 | Cephea Early Feasibility Study The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1936879820316496

Early Experience With a Novel Transfemoral Mitral Valve ... In accordance with this single-center experience, the Cephea valve system showed a very high procedural success rate in 3 consecutive patients, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10198241/

Transcatheter Mitral Valve Replacement with Dedicated ... According to the Mitral Valve Academic Research Consortium definitions, technical success was achieved in 96% of the patients, along with 94% ...

5. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/ABT-CIP-10354

Cephea Early Feasibility Study - Cedars-Sinai's clinical trials Specifically, the study aims to determine the safety and effectiveness of the Cephea Mitral Valve system for the treatment of a leaking mitral valve.