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RecruitingNCT03692598STTARUpdated Oct 23, 2024

Study of Transcatheter Tricuspid Annular Repair

An interventional study of MIA, Minimally Invasive Annuloplasty Device - Surgical and MIA, Minimally Invasive Annuloplasty Device - Percutaneous in Tricuspid Regurgitation, sponsored by Micro Interventional Devices. Recruiting at 6 sites in 5 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-10-23.

Sponsored by Micro Interventional Devices · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2016; still recruiting 9 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Tricuspid Regurgitation
03

In context

Tricuspid Valve Insufficiency

219 studies on the registry are indexed under Tricuspid Valve Insufficiency; 106 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 118 interventional studies indexed under Tricuspid Valve Insufficiency.

Browse Tricuspid Valve Insufficiency studies →

Lead sponsor

Micro Interventional Devices is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation (2-4)
  2. Age≥18 and ≤85 years old
  3. New York Heart Association (NYHA) Class II, III or ambulatory IV
  4. Left ventricular ejection fraction (LVEF) ≥30%
  5. Undergoing cardiac surgical procedure with the planned use of cardiopulmonary bypass (surgical arm only)
  6. 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
  7. Patient provides written Informed Consent before any study-specific tests or procedures are performed
  8. Patient is willing and able to comply with all specified study evaluations

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or lactating female
  2. Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg)
  3. Previous tricuspid valve repair or replacement
  4. Myocardial Infarction or known unstable angina within the 30-days prior to the index procedure
  5. Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure
  6. Life expectancy of less than 12-months
  7. Severe right heart dysfunction
  8. Pulmonary hypertension with PA mean 2/3 rd MAP
  9. Active systemic infection
  10. Pericardial infection
  11. Any clinical evidence that the investigator feels would place the patient at increased risk with the deployment of the device
  12. 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)
  13. Untreated coronary artery disease (CAD) requiring revascularisation unless CABG procedure is concomitant with MIA tricuspid annular repair (surgical arm only)
  14. Haemodynamic instability: systolic blood pressure \<90mmHg without reduction of afterload, shock, need for inotropic medication or IABP
  15. Active peptic ulcer or gastrointestinal (GI) bleeding in the past 3 months
  16. Cerebrovascular event within the past 6 months
  17. History of mitral/tricuspid endocarditis within the last 12 months
  18. Organic tricuspid disease
  19. Contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated
  20. Known alcohol or drug abuser
  21. Currently participating in the study of an investigational drug or device
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    MIA Surgical

    Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Surgical from an open surgical approach

    Device: MIA, Minimally Invasive Annuloplasty Device - Surgical

  • Experimental
    MIA Percutaneous

    Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Percutaneous from a transcatheter approach

    Device: MIA, Minimally Invasive Annuloplasty Device - Percutaneous

Interventions

  • DeviceMIA, Minimally Invasive Annuloplasty Device - Surgical

    Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from an open surgical approach

    Also known as: MIA-S

  • DeviceMIA, Minimally Invasive Annuloplasty Device - Percutaneous

    Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from a percutaneous approach

    Also known as: MIA

06

What researchers measure

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 days

  2. 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 days

Secondary 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 months

  2. 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 months

  3. 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 months

07

Study locations

3 of 6 sites recruiting
  • Aarhus University Hospital
    Aarhus, Denmark
    • Steen H Poulsen · Contact
    Not yet recruiting
  • Semmelweis University, Heart and Vascular Center
    Budapest, Hungary
    • Bela Merkely · Contact
    Not yet recruiting
  • Centre of Cardiology, Pauls Stradins Clinical University Hospital
    Riga, Latvia
    • Andrejs Erglis · Contact
    Recruiting
  • Lithuanian University of Health Sciences
    Kaunas, 50009, Lithuania
    • Rimantas Benetis · Contact
    Recruiting
  • Vilnius University Hospital Santariskiu Klinikos
    Vilnius, 08661, Lithuania
    Recruiting
  • The Cardinal Stefan Wyszyński Institute of Cardiology
    Warsaw, Poland
    • Marcin Demkow · Contact
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03692598
Lead sponsor
Micro Interventional Devices
Responsible party
Sponsor
First posted
Oct 2, 2018
Start date
Dec 2016
Primary completion
Dec 2025 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 23, 2024

Study contacts

Angie Swenson
Contact
aswenson@microinterventional.com
Kestutis Rucinskas, MD
principal investigator · Vilnius University Hospital, Santariskiu Klinikos

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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