Functional Tricuspid Regurgitation
Conditions
Keywords
FTR, RV failure, TauPnu
Brief summary
evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tricuspid regurgitation
Detailed description
evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tri cuspid regurgitation : multi-center, open label, single arm, investigator initiated exploratory pilo t study
Interventions
DEVICEPivot Bridge
transcatheter for short-term treat Functional Tricuspid regurgitation
Sponsors
Tau-MEDICAL Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult males and females aged 20 years or above * Patients with clinical symptoms (Symptomatic) whose degree of tricuspid regurgitation using echocardiography meets the criteria of Severe or higher presented in the TR grade classification table * Short-term treatment using a catheter is required (expected to be effective) by a local site heart team including at least one cardiothoracic (cardiovascular) specialist and at least one thoracic surgeon each, and clinical symptoms of NYHA Class Ⅱ or higher person who falls under * In the screening test, A person who can confirm the possibility of reducing tricuspid valve regurgitation by inserting that 'Pivot Balloon' (Clinical Trial Approval No. 1327), etc.) through the same access path as the 'Pivot Bridge', a clinical trial medical device * An individual who voluntarily agreed to the participation in the clinical trial and signed the written consent * An individual who is able to understand and comply with the instructions and who can participate in the period before the clinical trial
Exclusion criteria
* Uncontrolled hyperthyroidism * A recent formation of soft blood clot or embolic material * Uncorrected coagulopathy * Prohibition of anticoagulant agents * Those who had experience with anticoagulant use prior to participation in this clinical trial and who were treated with major bleeding (minor bleeding such as nosebleeds that can be hemostasis not applicable) due to anticoagulant use at this time or accompanied by severe anemia requiring hospitalization one with experience * Previous insertion of a device such as an Implantable Cardioverter Defibrillator (ICD) or a pacemaker * Those who is judged to have little possibility of reducing tricuspid valve regurgitation by inserting a balloon-type device (e.g. ASD sizing balloon, pivot balloon, etc.) through the same access route as the clinical trial medical device 'Pivot Bridge' * Persons with an anatomical structure that cannot be inserted through the corresponding route
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Acute phase safety | immediately after the procedure | Check all adverse reactions Including serious adverse events and serious adverse medical device reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy endpoint-1: Changes of hemodynamics(1) | within 1week of implant | Echocardiogram: RV Cardiac output(Heart rate x RVOT area x RVOT TVI) in ml/min |
| Efficacy endpoint-1: Changes of hemodynamics(2) | within 1week of implant | Echocardiogram: Fractional area change in percentage |
| Efficacy endpoint-1: Changes of hemodynamics(3) | within 1week of implant | Echocardiogram: LVEF in percentage |
| Efficacy endpoint-1: Changes of hemodynamics(4) | within 1week of implant | Echocardiogram: Peak systolic annular velocity in cm/sec |
| Efficacy endpoint-1: Changes of hemodynamics(5) | within 1week of implant | Echocardiogram: Tricuspid annular plane systolic excursion(TAPSE) in mm |
| Efficacy endpoint-1: Changes of hemodynamics(6) | within 1week of implant | Echocardiogram: LVOT stroke volume in ml |
| Efficacy endpoint-1: Changes of hemodynamics | within 1week of implant | Echocardiogram: Pulmonay artery forward flow(RV stroke volume) in ml |
| Efficacy endpoint-1: Changes of hemodynamics(8) | within 1week of implant | Echocardiogram: RV diameter base in mm |
| Efficacy endpoint-1: Changes of hemodynamics(9) | within 1week of implant | Echocardiogram: Inferior vena cava diameter and PW tracing - Assessment of the presence or absence of systolic flow reversal |
| Efficacy endpoint-1: Changes of hemodynamics(10) | within 1week of implant | Echocardiogram: RV-RA coupling(Tapse/PASP) in ratio |
| Assessment of short-term safety | within 1week of implant | Check all adverse reactions Including serious adverse events and serious adverse medical device reactions |
| Efficacy endpoint-1: Changes of hemodynamics(11) | within 1week of implant | Cardiac CT : RV volume in ml |
| Efficacy endpoint-2: Technical feasibility and TR grade changes | within 1week of implant | Evaluation of reduction in tricuspid regurgitation grade (TR grade) according to Echo parameters |
| Efficacy endpoint-1: Changes of hemodynamics(7) | within 1week of implant | Echocardiogram: TV annular diameter in mm |
Countries
South Korea
Outcome results
None listed