Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-008859
NCT ID: NCT03016975
Sponsor Protocol Number: 2017-05
About this study
To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age > 18 years
- Clinically Significant Functional Mitral Regurgitation (MR)
- Symptomatic heart failure
- Patient hospitalized due to heart failure during 12 months prior to submission to Central Screening Committee OR elevated Brain Natriuretic Peptid (BNP)
- Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit compliance
Exclusion Criteria:
- Primarily degenerative MR
- Mitral annular calcification that would impede implantation of device
- Other severe valve disorders requiring intervention
- Mitral valve anatomy which may preclude proper Edwards Cardioband deployment
- Life expectancy of less than twelve months
- Patient is participating in concomitant research studies of investigational products which have not reached their primary endpoint
- Unwillingness or inability to undergo follow-up investigations/visits
- Other medical, social, or psychological conditions that precludes appropriate consent and follow-up
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Guy Reeder, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available