RECRUITING

Abbott Cephea Mitral Valve Disease Registry

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 registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes in patients that could be candidates for Transcatheter Mitral Valve Replacement and may also inform future regulatory or reimbursement submission strategies for the Cephea Mitral Valve System.

Official Title

Abbott Cephea Mitral Valve Disease Registry

Quick Facts

Study Start:2025-08-13
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07069673

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. 1. Symptomatic mitral valve disease resulting in mitral regurgitation and/or severe mitral valve stenosis.
  2. 2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.
  3. 3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure.
  4. 4. Age 18 years or older at time of consent.
  5. 5. The subject agrees to the study requirements and to return for all required follow-up visits, and has provided written informed consent.
  1. 1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
  2. 2. Subject is undergoing hemodialysis or experiencing chronic renal failure
  3. 3. Subject has COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use
  4. 4. Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months.
  5. 5. Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.

Contacts and Locations

Study Contact

Cephea Project Manager
CONTACT
1+612.816.4605
cepheamvdregistry@abbott.com

Study Locations (Sites)

Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, 67214
United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

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 Date2025-08-13
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-08-13
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Mitral Valve Disease
  • registry
  • Cephea Mitral Valve System

Additional Relevant MeSH Terms

  • Mitral Regurgitation
  • Mitral Stenosis
  • Mitral Valve Disease
  • Mitral Valve (MV) Regurgitation
  • Mitral Annulus Calcification
  • Mitral Valve Replacement
  • Transcatheter Valve Replacement