Study of Transcatheter Tricuspid Annular Repair
ConditionTricuspid Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorMicro Interventional Devices
About this trial
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 criteria
Qualifiers
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%
Disqualifiers
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
Trial design
Treatments tested in this trial
- MIA, Minimally Invasive Annuloplasty Device - Surgical
- MIA, Minimally Invasive Annuloplasty Device - Percutaneous
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov