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Mitral Valve System

Cephea Valve System for Mitral Regurgitation

N/A

Recruiting

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post implant

Awards & highlights

Study Summary

This trial is testing a new transcatheter mitral valve replacement system to see if it is safe and effective in treating patients with severe mitral regurgitation who are not candidates for open heart surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed, similar procedures may include risks like bleeding, infection, damage to the heart or vessels, irregular heartbeats, stroke, or need for additional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days post implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days post implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post implant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Effectiveness Endpoint

Primary Safety Endpoint

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor

638 Previous Clinical Trials

404,466 Total Patients Enrolled

Barathi SethuramanStudy DirectorAbbott Structural Heart

3 Previous Clinical Trials

352 Total Patients Enrolled

Media Library

Cephea Mitral Valve System (Mitral Valve System) Clinical Trial Eligibility Overview. Trial Name: NCT05061004 — N/A

Mitral Valve Regurgitation Research Study Groups: Treatment

Mitral Valve Regurgitation Clinical Trial 2023: Cephea Mitral Valve System Highlights & Side Effects. Trial Name: NCT05061004 — N/A

Cephea Mitral Valve System (Mitral Valve System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05061004 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test centers are actively conducting this experiment?

"11 medical centres are currently enrolling participants for this trial, including Montefiore Medical Centre in Bronx, The Cleveland Clinic Foundation in Cleveland and The Methodist Hospital in Houston. Additionally, there are 8 other sites providing access to the treatment."

Answered by AI

Are there vacancies to enroll in this clinical research endeavor?

"Affirmative. The information available on clinicaltrials.gov attests to this medical trial's active recruitment status, which commenced at the end of April 2022 and was recently modified in late August 2022. This study requires 30 individuals across 11 different sites for its completion."

Answered by AI

How many subjects are being monitored for this clinical experiment?

"Affirmative, the information on clinicaltrials.gov suggests that this experiment is presently recruiting patients. It was posted on April 28th of 2022 and updated most recently on August 23rd; 30 people are needed across 11 sites for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cephea Early Feasibility Study

2022. "Cephea Early Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05061004.