Study of Transcatheter Tricuspid Annular Repair (STTAR)

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.

Study Overview

• Status: Recruiting
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Device: MIA, Minimally Invasive Annuloplasty Device - Surgical; Device: MIA, Minimally Invasive Annuloplasty Device - Percutaneous

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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angie Swenson; Email: aswenson@microinterventional.com

Study Locations

• Denmark
  • Aarhus, Denmark
    • Not yet recruiting
    • Aarhus University Hospital
    • Contact: Steen H Poulsen
• Hungary
  • Budapest, Hungary
    • Not yet recruiting
    • Semmelweis University, Heart and Vascular Center
    • Contact: Bela Merkely
• Latvia
  • Riga, Latvia
    • Recruiting
    • Centre of Cardiology, Pauls Stradins Clinical University Hospital
    • Contact: Andrejs Erglis
• Lithuania
  • Kaunas, Lithuania, 50009
    • Recruiting
    • Lithuanian University of Health Sciences
    • Contact: Rimantas Benetis
  • Vilnius, Lithuania, 08661
    • Recruiting
    • Vilnius University Hospital Santariskiu Klinikos
    • Contact: Kestutis Rucinskas, MD; Email: Kestutis.Rucinskas@santa.lt
    • Contact: Vilius Janusauskus, MD; Email: Vilius.Janusauskas@santa.lt
• Poland
  • Warsaw, Poland
    • Not yet recruiting
    • The Cardinal Stefan Wyszynski Institute of Cardiology
    • Contact: Marcin Demkow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: MIA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Micro Interventional Devices
• Investigators: Principal Investigator: Kestutis Rucinskas, MD, Vilnius University Hospital, Santariskiu Klinikos

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: MID-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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