Cephea Mitral Valve System for Mitral Valve Regurgitation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
St. Thomas Hospital, Nashville, TNMitral Valve RegurgitationCephea Mitral Valve System - Device
Eligibility
18+
All Sexes
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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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 30 days post implant

30 days post implant
Primary Effectiveness Endpoint
Primary Safety Endpoint

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Treatment
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Cephea Mitral Valve System · No Placebo Group · N/A

Treatment
Device
Experimental Group · 1 Intervention: Cephea Mitral Valve System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days post implant

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
601 Previous Clinical Trials
365,301 Total Patients Enrolled
Barathi SethuramanStudy DirectorAbbott Structural Heart
3 Previous Clinical Trials
384 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.