Tricuspid RegurgitationSTTARNCT03692598
Study of Transcatheter Tricuspid Annular Repair
A study testing MIA, Minimally Invasive Annuloplasty Device - Surgical and MIA, Minimally Invasive Annuloplasty Device - Percutaneous in people with Tricuspid Regurgitation, run by Micro Interventional Devices at 6 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- MIA, Minimally Invasive Annuloplasty Device - Surgical and MIA, Minimally Invasive Annuloplasty Device - Percutaneous
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Dec 2016to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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 immunosuppression)
- 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
Trial locations and contacts
6 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Angie Swenson contact
6 sites in 5 countries
Lithuania2 sites, 2 recruiting
- Recruiting
Lithuanian University of Health Sciences
Kaunas, 50009
Rimantas Benetis
- Recruiting
Vilnius University Hospital Santariskiu Klinikos
Vilnius, 08661
Kestutis Rucinskas, MD, Kestutis.Rucinskas@santa.lt
Vilius Janusauskus, MD, Vilius.Janusauskas@santa.lt
Denmark1 site, 1 recruiting
- Not yet recruiting
Aarhus University Hospital
Aarhus
Steen H Poulsen
Hungary1 site, 1 recruiting
- Not yet recruiting
Semmelweis University, Heart and Vascular Center
Budapest
Bela Merkely
Latvia1 site, 1 recruiting
- Recruiting
Centre of Cardiology, Pauls Stradins Clinical University Hospital
Riga
Andrejs Erglis
Poland1 site, 1 recruiting
- Not yet recruiting
The Cardinal Stefan Wyszyński Institute of Cardiology
Warsaw
Marcin Demkow
About this study
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.
Read the 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.
- Conditions
- Tricuspid Regurgitation
- Being tested
- MIA, Minimally Invasive Annuloplasty Device - Surgical, MIA, Minimally Invasive Annuloplasty Device - Percutaneous
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIA, Minimally Invasive Annuloplasty Device - SurgicalDevice
Also called MIA-S
Eligible 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 - PercutaneousDevice
Also called MIA
Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from a percutaneous approach
| Study group | Role | What they receive |
|---|---|---|
| MIA Surgical | Experimental | Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Surgical from an open surgical approach Receives: Device: MIA, Minimally Invasive Annuloplasty Device - Surgical |
| MIA Percutaneous | Experimental | Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Percutaneous from a transcatheter approach Receives: Device: MIA, Minimally Invasive Annuloplasty Device - Percutaneous |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
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
Measured: 30 days
Secondary outcomes (3)
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.
Measured: 3 months
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.
Measured: 3 months
Quality of Life Measurement
Change in quality of life questionnaire (Minnesota Living with Heart Failure Questionnaire) compared to baseline at 6 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study startDec 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Micro Interventional Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kestutis Rucinskas, MD, Principal investigator, Vilnius University Hospital, Santariskiu Klinikos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692598
- Sponsor's protocol ID
- MID-002
- Acronym
- STTAR
- Status last verified
- Oct 2024
- First submitted
- 2 Dec 2016
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Transcatheter Tricuspid Annular Repair
- ClinicalTrials.gov ID
- NCT03692598
- Acronym / sponsor ID
- STTAR / MID-002
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Micro Interventional DevicesIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIA Surgical | Experimental | Device: MIA, Minimally Invasive Annuloplasty Device - SurgicalEligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Surgical from an open surgical approach |
| MIA Percutaneous | Experimental | Device: MIA, Minimally Invasive Annuloplasty Device - PercutaneousEligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Percutaneous from a transcatheter approach |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIA, Minimally Invasive Annuloplasty Device - SurgicalAlso: MIA-SEligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from an open surgical approach | Device | MIA Surgical |
| MIA, Minimally Invasive Annuloplasty Device - PercutaneousAlso: MIAEligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from a percutaneous approach | Device | MIA Percutaneous |
Primary outcome
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
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
3 secondary outcomes
Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE)
Time frame: 3 months
Reduction in tricuspid regurgitation
Time frame: 3 months
Quality of Life Measurement
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Tricuspid Regurgitation
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
Not yet recruiting
TRI-SUCCESS - Tricuspid Regurgitation Study of the Unica™ Cross-Caval System for the Evaluation of Efficacy and Safety in Significant TR Subjects
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Recruiting
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angie Swenson contact
Kestutis Rucinskas, MD principal investigator
Vilnius University Hospital, Santariskiu Klinikos
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIA, Minimally Invasive Annuloplasty Device - Surgical and MIA, Minimally Invasive Annuloplasty Device - Percutaneous in people with Tricuspid Regurgitation, run by Micro Interventional Devices at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Lithuania, Denmark, Hungary, Latvia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angie Swenson (aswenson@microinterventional.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.