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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
MIA, Minimally Invasive Annuloplasty Device - Surgical
DeviceEligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from an open surgical approach
MIA, Minimally Invasive Annuloplasty Device - Percutaneous
DeviceEligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from a percutaneous approach
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: MIA SurgicalExperimental treatment 1 intervention
Group B: MIA PercutaneousExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Major Adverse Events
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
Time frame
30 days2
Reduction in tricuspid regurgitation at 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
Time frame
30 daysSecondary outcomes
1
Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE)
The percentage of participants with Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE) within 6 months of the procedure will be compared to the literature.
Time frame
3 months2
Reduction in tricuspid regurgitation
Assessment in the degree of Tricuspid Regurgitation at 3 months compared to baseline Ability to maintain improvement in tricuspid regurgitation with respect to baseline.
Time frame
3 months3
Quality of Life Measurement
Change in quality of life questionnaire (Minnesota Living with Heart Failure Questionnaire) compared to baseline at 6 months
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov