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New treatment option for Tricuspid Regurgitation
Official title Study of Transcatheter Tricuspid Annular Repair
ClinicalTrials.gov ID: NCT03692598
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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
- 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
- Any clinical evidence that the investigator feels would place the patient at increased risk with the deployment of the device
- Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe...
- Untreated coronary artery disease (CAD) requiring revascularisation unless CABG procedure is concomitant with MIA tricuspid annular repair (surgical arm only)
- Haemodynamic instability: systolic blood pressure \<90mmHg without reduction of afterload, shock, need for inotropic medication or IABP
- Active peptic ulcer or gastrointestinal (GI) bleeding in the past 3 months
- Cerebrovascular event within the past 6 months
- History of mitral/tricuspid endocarditis within the last 12 months
- Organic tricuspid disease
- Contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated
- Known alcohol or drug abuser
- Currently participating in the study of an investigational drug or device
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Budapest, Hungary
- Riga, Latvia
- Kaunas, Lithuania
- Vilnius, Lithuania
- Warsaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark; Budapest, Hungary; Riga, Latvia; Kaunas, Lithuania; Vilnius, Lithuania; Warsaw, Poland. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.