NCT04529928

An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Cardiac Dimensions Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this prospective, multi-center trial is to assess the effectiveness of the CARILLON Mitral Contour System in treating patients with moderate-to-severe atrial functional mitral regurgitation (aFMR)

Detailed 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 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.

Conditions

• Functional Mitral Regurgitation
• Atrial Fibrillation
• Atrial Functional Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	Carillon Mitral Contour System	Eligible subjects will be implanted with the Carillon Device, utilizing the Carillon Mitral Contour System. The device is a permanent implant in the coronary sinus/great cardiac vein, designed to cinch the mitral annulus. The implant procedure is minimally invasive, conducted via catheter placement.

Timeline

• Start date: 2020-10-19
• Primary completion: 2021-09-22
• Completion: 2022-12-22
• First posted: 2020-08-28
• Last updated: 2023-03-17

Locations

2 sites across 2 countries: Australia, Greece