Study of Transcatheter Tricuspid Annular Repair
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tricuspid Regurgitation
- Sponsor
- Micro Interventional Devices
- Enrollment
- 60
- Locations
- 6
- Primary Endpoint
- Reduction in tricuspid regurgitation at 30 days
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
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. The study is a prospective, multi-center safety and performance study. Enrolled subjects will be assessed for clinical follow-up at 1 month, 6 months, and 1 year post implant procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Pregnant or lactating female
- •Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg)
- •Previous tricuspid valve repair or replacement
- •Myocardial Infarction or known unstable angina within the 30-days prior to the index procedure
- •Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure
- •Life expectancy of less than 12-months
- •Severe right heart dysfunction
- •Pulmonary hypertension with PA mean 2/3 rd MAP
- •Active systemic infection
- •Pericardial infection
Outcomes
Primary Outcomes
Reduction in tricuspid regurgitation at 30 days
Time Frame: 30 days
The reduction in the degree of tricuspid regurgitation compared to baseline measured post-procedure, at post-operative hospital discharge and at 1 month post-operative. Ability to reduce tricuspid regurgitation by at least 1 degree by means of quantitative echocardiographic parameters
Major Adverse Events
Time Frame: 30 days
The percentage of participants with Major Adverse Events within 30 days of the procedure: death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed MIA implantation, or stroke
Secondary Outcomes
- Quality of Life Measurement(3 months)
- Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE)(3 months)
- Reduction in tricuspid regurgitation(3 months)