RECRUITING

Cephea Early Feasibility Study

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Conditions

Mitral Regurgitation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.

Official Title

Cephea Early Feasibility Study

Quick Facts

Study Start:2022-04-28
Study Completion:2031-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05061004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * LVEF ≥ 30%
  3. * In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.
  1. * Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
  2. * Need for emergent or urgent surgery.

Contacts and Locations

Study Contact

Shimako Nakajima
CONTACT
+1 408-845-0873
shimako.nakajima@abbott.com

Principal Investigator

Barathi Sethuraman
STUDY_DIRECTOR
Abbott Structural Heart

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of California - Davis Medical Center
Sacramento, California, 95817
United States
Piedmont Heart Institute
Atlanta, Georgia, 30309
United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Carolinas Medical Center
Charlotte, North Carolina, 28203
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
St. Thomas Hospital
Nashville, Tennessee, 37205
United States
The Methodist Hospital
Houston, Texas, 77030
United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

  • Barathi Sethuraman, STUDY_DIRECTOR, Abbott Structural Heart

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-28
Study Completion Date2031-03-01

Study Record Updates

Study Start Date2022-04-28
Study Completion Date2031-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • Mitral Regurgitation