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Bioprostheses

Bioprosthetic Mitral Valve for Mitral Valve Regurgitation

N/A

Waitlist Available

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

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

Must have

The patient is 18 years or older.

The patient is expected to survive the surgery and be discharged.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 years post-implant

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of the Carpentier-Edwards Magna Mitral Valve in patients undergoing mitral valve replacement.

Who is the study for?

This trial is for adults over 18 who need a mitral valve replacement, are stable enough to survive surgery and be discharged, can attend follow-ups, and have signed consent forms. It's not for those with life-threatening non-cardiac diseases, recent endocarditis, pregnancy or lactation, drug abuse issues, imprisonment status or involvement in other drug/device trials.Check my eligibility

What is being tested?

The study aims to confirm the long-term safety and effectiveness of Carpentier-Edwards PERIMOUNT Magna Mitral Valves in patients needing mitral valve replacements. This may include additional procedures that require cardiopulmonary bypass during the implantation process.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical risks associated with heart valve replacement surgeries can include bleeding complications, infection risk at the surgical site or within the body (endocarditis), stroke due to blood clots forming on the new valve which could travel to brain vessels causing blockage.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am expected to survive my upcoming surgery and leave the hospital.

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I need a new mitral valve based on my pre-surgery assessment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 years post-implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 years post-implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 years 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 Endpoints

Primary Safety Endpoints

Secondary outcome measures

Secondary Effectiveness Endpoints

Secondary Safety Endpoints

Trial Design

1Treatment groups

Experimental Treatment

Group I: Device - CEP Mitral ValveExperimental Treatment1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor

180 Previous Clinical Trials

61,245 Total Patients Enrolled

Mary EdwardsStudy DirectorEdwards Lifesciences

Jennifer Currin, PhDStudy DirectorEdwards Lifesciences

Media Library

CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES (Bioprostheses) Clinical Trial Eligibility Overview. Trial Name: NCT00853632 — N/A

Mitral Valve Regurgitation Research Study Groups: Device - CEP Mitral Valve

Mitral Valve Regurgitation Clinical Trial 2023: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES Highlights & Side Effects. Trial Name: NCT00853632 — N/A

CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES (Bioprostheses) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00853632 — N/A

Frequently Asked Questions

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

Is participation currently being solicited for this experiment?

"According to the details present on clinicaltrials.gov, this trial is no longer actively accepting participants. Initially posted in August of 2007, it was last edited 27th January 2022; however there are still 1302 trials recruiting now."

Answered by AI

Is there a substantial amount of research facilities conducting this trial in the North American region?

"Presently, the trial is being conducted in 12 different medical centres situated in cities such as Orlando, Grand Rapids and Saint Louis. It is suggested that prospective participants choose a site near them to reduce travel costs and other associated demands."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

2007. "Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00853632.

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