Study of Transcatheter Tricuspid Annular Repair

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation (2-4)

• Age≥18 and ≤85 years old

• New York Heart Association (NYHA) Class II, III or ambulatory IV

• Left ventricular ejection fraction (LVEF) ≥30%

• Undergoing cardiac surgical procedure with the planned use of cardiopulmonary bypass (surgical arm only)

• Functional tricuspid valve regurgitation pathology with a structurally normal valve; and tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2) and ≤55 mm (or 29 mm/m2) or 2-4 + FTR

• Patient provides written Informed Consent before any study-specific tests or procedures are performed

• Patient is willing and able to comply with all specified study evaluations

Locations
Other Locations
Denmark
Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus
Hungary
Semmelweis University, Heart and Vascular Center
NOT_YET_RECRUITING
Budapest
Latvia
Centre of Cardiology, Pauls Stradins Clinical University Hospital
RECRUITING
Riga
Lithuania
Lithuanian University of Health Sciences
RECRUITING
Kaunas
Vilnius University Hospital Santariskiu Klinikos
RECRUITING
Vilnius
Poland
The Cardinal Stefan Wyszyński Institute of Cardiology
NOT_YET_RECRUITING
Warsaw
Contact Information
Primary
Angie Swenson
aswenson@microinterventional.com
Time Frame
Start Date: 2016-12
Estimated Completion Date: 2026-12
Participants
Target number of participants: 60
Treatments
Experimental: MIA Surgical
Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Surgical from an open surgical approach
Experimental: MIA Percutaneous
Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Percutaneous from a transcatheter approach
Related Therapeutic Areas
Sponsors
Leads: Micro Interventional Devices

This content was sourced from clinicaltrials.gov