An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atrial Fibrillation
- Atrial Functional Mitral Regurgitation
- Functional Mitral Regurgitation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The AFIRE Trial is a prospective, multi-center clinical trial. The centers will utilize pre-screening of existing medical records to identify potentially eligible subjects. Once informed consent has been obtained, the subject will undergo baseline assessments, which include: Transthoracic echocardio...
The AFIRE Trial is a prospective, multi-center clinical trial. The centers will utilize pre-screening of existing medical records to identify potentially eligible subjects. Once informed consent has been obtained, the subject will undergo baseline assessments, which include: Transthoracic echocardiography, transesophageal echocardiography, and functional assessments (Six-Minute Walk Test, NYHA, and Quality of Life Questionnaires). Following final eligibility determination, eligible subjects will under the index procedure to implant the Carillon device (includes coronary sinus venogram). Subject will be discharged following one-night in-hospital stay and discharge assessments. Subjects who have the Carillon implant procedure attempted but were not successfully implanted (Non-Implanted subjects) will be followed through discharge or resolution of safety events, whichever is longer, and then discharged from the trial. Implanted subjects will have follow-up assessments performed at 1 month, 6 months, and 12 months post index procedure. Follow-up assessments will include transthoracic echocardiography, Six-Minute Walk Test, and Quality of Life Questionnaires.
Tracking Information
- NCT #
- NCT04529928
- Collaborators
- Not Provided
- Investigators
- Not Provided