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Study of Transcatheter Tricuspid Annular Repair (STTAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03692598
Recruitment Status : Unknown
Verified February 2021 by Micro Interventional Devices.
Recruitment status was:  Recruiting
First Posted : October 2, 2018
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Micro Interventional Devices

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Tricuspid Regurgitation Device: MIA, Minimally Invasive Annuloplasty Device - Surgical Device: MIA, Minimally Invasive Annuloplasty Device - Percutaneous Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Transcatheter Tricuspid Annular Repair
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022
Arms and Interventions
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Arm Intervention/treatment
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
Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from an open surgical approach
Other Name: MIA-S
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
Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from a percutaneous approach
Other Name: MIA


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE) [ Time Frame: 3 months ]
    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.

  2. Reduction in tricuspid regurgitation [ Time Frame: 3 months ]
    Assessment in the degree of Tricuspid Regurgitation at 3 months compared to baseline Ability to maintain improvement in tricuspid regurgitation with respect to baseline.

  3. Quality of Life Measurement [ Time Frame: 3 months ]
    Change in quality of life questionnaire (Minnesota Living with Heart Failure Questionnaire) compared to baseline at 6 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692598


Contacts
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Contact: Willard Hennemann, PhD 215 600-1273 bhennemann@microinterventional.com
Contact: Jeremy L West 6127566791 jwest@microinterventional.com

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark
Contact: Steen H Poulsen         
Hungary
Semmelweis University, Heart and Vascular Center Recruiting
Budapest, Hungary
Contact: Bela Merkely         
Latvia
Centre of Cardiology, Pauls Stradins Clinical University Hospital Recruiting
Riga, Latvia
Contact: Andrejs Erglis         
Lithuania
Lithuanian University of Health Sciences Recruiting
Kaunas, Lithuania, 50009
Contact: Rimantas Benetis         
Vilnius University Hospital Santariskiu Klinikos Recruiting
Vilnius, Lithuania, 08661
Contact: Kestutis Rucinskas, MD       Kestutis.Rucinskas@santa.lt   
Contact: Vilius Janusauskus, MD       Vilius.Janusauskas@santa.lt   
Poland
The Cardinal Stefan Wyszyński Institute of Cardiology Recruiting
Warsaw, Poland
Contact: Marcin Demkow         
Sponsors and Collaborators
Micro Interventional Devices
Investigators
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Principal Investigator: Kestutis Rucinskas, MD Vilnius University Hospital, Santariskiu Klinikos
More Information
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Responsible Party: Micro Interventional Devices
ClinicalTrials.gov Identifier: NCT03692598    
Other Study ID Numbers: MID-002
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases