Study of Transcatheter Tricuspid Annular Repair

Tricuspid Regurgitation Clinical Trial

— STTAR  

Official title:

Study of Transcatheter Tricuspid Annular Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03692598
• Other study ID #: MID-002
• Status: Recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2022

Study information

• Verified date: February 2021
• Source: Micro Interventional Devices
• Contact: Willard Hennemann, PhD
• Phone: 215 600-1273
• Email: bhennemann[@]microinterventional.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

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
• 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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Hungary	Semmelweis University, Heart and Vascular Center	Budapest
Latvia	Centre of Cardiology, Pauls Stradins Clinical University Hospital	Riga
Lithuania	Lithuanian University of Health Sciences	Kaunas
Lithuania	Vilnius University Hospital Santariskiu Klinikos	Vilnius
Poland	The Cardinal Stefan Wyszynski Institute of Cardiology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Micro Interventional Devices

Countries where clinical trial is conducted

Denmark,  Hungary,  Latvia,  Lithuania,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Quality of Life Measurement	Change in quality of life questionnaire (Minnesota Living with Heart Failure Questionnaire) compared to baseline at 6 months	3 months