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Study of Transcatheter Tricuspid Annular Repair (STTAR)

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ClinicalTrials.gov Identifier: NCT03692598
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Micro Interventional Devices

Tracking Information
First Submitted Date  ICMJE December 2, 2016
First Posted Date  ICMJE October 2, 2018
Last Update Posted Date September 1, 2021
Actual Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Transcatheter Tricuspid Annular Repair
Official Title  ICMJE Study of Transcatheter Tricuspid Annular Repair
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tricuspid Regurgitation
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: Device: MIA, Minimally Invasive Annuloplasty Device - Percutaneous
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2020)
60
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Willard Hennemann, PhD 215 600-1273 bhennemann@microinterventional.com
Contact: Jeremy L West 6127566791 jwest@microinterventional.com
Listed Location Countries  ICMJE Denmark,   Hungary,   Latvia,   Lithuania,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03692598
Other Study ID Numbers  ICMJE MID-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Micro Interventional Devices
Study Sponsor  ICMJE Micro Interventional Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kestutis Rucinskas, MD Vilnius University Hospital, Santariskiu Klinikos
PRS Account Micro Interventional Devices
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP