Evaluation of Safety and Feasibility of the Tioga TMVR System for Treatment of Mitral Regurgitation
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR\>=3+)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age 18 years or older
• Symptomatic, moderate to severe (3+) or severe (4+) MR
• NYHA Functional Classification ≥ II
• Heart team concurs that the subject is non-ideal for surgical intervention or other available treatment options (e.g., TEER)
• The subject or the subject's legal representative has been informed of the nature of the study, has agreed to return for post-procedure follow-up visits, and has provided informed consent
Locations
Other Locations
Brazil
Incor - Instituto do Coração do Hospital das Clínicas da FMUSP
RECRUITING
São Paulo
Georgia
Helsicore Hospital (Israeli Georgeian Medical Research Clinic Healthycore)
RECRUITING
Tbilisi
Tbilisi Heart and Vascular Clinic
RECRUITING
Tbilisi
Lithuania
Vilnius Univ. Hospital
RECRUITING
Vilnius
Paraguay
Sanatorio Italiano
RECRUITING
Asunción
Contact Information
Primary
Mariam Maghribi
mariam@tiogamed.com
510-705-2569
Backup
Tom Kelly
tkelly@tiogamed.com
510-304-1117
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 30
Treatments
Experimental: Patients with Symptomatic MR (MR>=3+)
Subjects treated with the Tioga TMVR System
Related Therapeutic Areas
Sponsors
Leads: Tioga Cardiovascular, Inc.