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Recruiting NCT03692598

Study of Transcatheter Tricuspid Annular Repair

No phase Interventional Tricuspid Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MIA, Minimally Invasive Annuloplasty Device - Surgical, MIA, Minimally Invasive Annuloplasty Device - Percutaneous.
Who it may be relevant to
Registry conditions: Tricuspid Regurgitation. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark, Hungary, Latvia, Lithuania, Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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
  • 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

Primary outcome measures

  • Major Adverse Events [Time frame: 30 days]
  • Reduction in tricuspid regurgitation at 30 days [Time frame: 30 days]
Secondary outcome measures (3)
  • Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE) [Time frame: 3 months]
  • Reduction in tricuspid regurgitation [Time frame: 3 months]
  • Quality of Life Measurement [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Cerebrovascular event within the past 6 months
  • History of mitral/tricuspid endocarditis within the last 12 months
  • Organic tricuspid disease
  • Contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated
  • Known alcohol or drug abuser
  • Currently participating in the study of an investigational drug or device

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Lithuania · 2 centers
  • Lithuanian University of Health Sciences — Kaunas
  • Vilnius University Hospital Santariskiu Klinikos — Vilnius
Denmark · 1 center
  • Aarhus University Hospital — Aarhus
Hungary · 1 center
  • Semmelweis University, Heart and Vascular Center — Budapest
Latvia · 1 center
  • Centre of Cardiology, Pauls Stradins Clinical University Hospital — Riga
Poland · 1 center
  • The Cardinal Stefan Wyszyński Institute of Cardiology — Warsaw

Identifiers

NCT: NCT03692598 · MID-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗