None listed
Conditions
Interventions
Medical Device : ? The clinical trial subjects' procedures should be sterilized in an appropriate treatment location (cardiovascular room or hybrid room) that can ensure sufficient safety of the subje
Sponsors
Samsung Medical Center
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult males and females aged 20 years or above. 2) Patients with clinical symptoms whose tricuspid regurgitation using echocardiography corresponds to Severe or higher criteria presented in the classification table of TR grade. 3) Short-term treatment using catheters is required (expected to be effective) in the Local Site Heart Team, which includes at least one cardiologist and cardiothoracic surgeon, respectively, and falls under NYHA Class II or higher clinical symptoms. 4) Individuals exhibiting a potential reduction in TR on the screening test via insertion of a balloon-like device (e.g., ASD sizing balloon, pivot balloon, etc.) through an identical approach as that used for the “Pivot Bridge.” 5) Individuals who voluntarily agree to participation in the clinical trial and provide written informed consent. 6) Individuals with the ability to understand and comply with the instructions and who can participate in the pre-clinical trial procedures.
Exclusion criteria
Exclusion criteria: 1) Uncontrolled hyperthyroidism 2) Recent formation of a soft blood clot or embolic material 3) Uncorrected coagulopathy 4) Prohibition of anticoagulant agents 5) Those who have used anticoagulants prior to participating in this clinical trial and have been treated with major bleeding (minor bleeding, such as hemostatic nosebleeds), or have severe anemia that requires inpatient treatment 6) Previous insertion of devices such as implantable cardioverter defibrillators (ICDs) or pacemakers 7) Low probability of reduction in TR through the insertion of a balloon-like device (e.g., ASD sizing balloon, pivot balloon, etc.) using a route identical to that used for “Pivot Bridge” insertion on the screening test 8) Prohibition of device insertion based on anatomical structure 9) Pregnant or lactating mother, or a female patient planning pregnancy during the period of clinical trial, or a female not using an approved contraceptive with the possibility of pregnancy 10) Participation in another clinical trial 30 days prior to the screening 11) Individuals with clinical findings deemed unsuitable for the clinical trial by the Principal Investigator or the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke, pulmonary embolism, New renal failure, severe bleeding, Device related infection, Thrombus, Re-intervention, Serious side effects requiring treatment of other treatment areas | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary arterial forward flow (PW Doppler at the annulus level of the pulmonary valve), Right ventricular output (heart rate x RVOT area x RVOT TVI), fractional area change, peak systolic annular velocity, tricuspid annular plane systolic excursion, systolic flow reversal based on inferior vena cava diameter and PW tracing, Left ventricular volume, | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung-Whan Lee
Asan Medical Center
Outcome results
None listed