Study of Transcatheter Tricuspid Annular Repair

NCT03692598 | Recruiting DMC

• 1 other identifier: MID-002
• Study Type: interventional
• Target: 60
• Locations: 5 countries
• Sites: 6

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.

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE)

  3 months

• Reduction in tricuspid regurgitation

  3 months

• Quality of Life Measurement

  3 months

Study Arms (2)

MIA Surgical

EXPERIMENTAL

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

MIA Percutaneous

EXPERIMENTAL

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

MIA, Minimally Invasive Annuloplasty Device - Surgical DEVICE

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

MIA Surgical

MIA, Minimally Invasive Annuloplasty Device - Percutaneous DEVICE

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

Also known as: MIA

MIA Percutaneous

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or lactating female
• Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg)
• Previous tricuspid valve repair or replacement
• Myocardial Infarction or known unstable angina within the 30-days prior to the index procedure
• Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure
• Life expectancy of less than 12-months
• Severe right heart dysfunction
• Pulmonary hypertension with PA mean 2/3 rd MAP
• Active systemic infection
• Pericardial infection
• Any clinical evidence that the investigator feels would place the patient at increased risk with the deployment of the device
• 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)
• Untreated coronary artery disease (CAD) requiring revascularisation unless CABG procedure is concomitant with MIA tricuspid annular repair (surgical arm only)
• Haemodynamic instability: systolic blood pressure \<90mmHg without reduction of afterload, shock, need for inotropic medication or IABP
• Active peptic ulcer or gastrointestinal (GI) bleeding in the past 3 months

Sponsors & Collaborators

• Micro Interventional Devices: lead

Study Sites (6)

Aarhus University Hospital

Aarhus, Denmark

NOT YET RECRUITING

Semmelweis University, Heart and Vascular Center

Budapest, Hungary

NOT YET RECRUITING

Centre of Cardiology, Pauls Stradins Clinical University Hospital

Riga, Latvia

RECRUITING

Lithuanian University of Health Sciences

Kaunas, 50009, Lithuania

RECRUITING

Vilnius University Hospital Santariskiu Klinikos

Vilnius, 08661, Lithuania

RECRUITING

The Cardinal Stefan Wyszyński Institute of Cardiology

Warsaw, Poland

NOT YET RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Kestutis Rucinskas, MD

  Vilnius University Hospital, Santariskiu Klinikos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angie Swenson

CONTACT

aswenson@microinterventional.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: October 2, 2018
• Study Start: December 1, 2016
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1); HU (1); DK (1); LI (2); PL (1)