Comparing 3 approaches for tricuspid regurgitation (TR)

Exclusion

• −Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media.
• −Left ventricular ejection fraction (LVEF) \<35%.
• −Pulmonary arterial systolic pressure (PASP) \>60 mmHg by echo Doppler (unless right heart catheterization \[RHC\] demonstrates PASP ≤60mmHg); in case RHC is performed, PASP \>2/3 systemic BP with PVR \>5 Wood units after vasodilator challenge, in the absence of symptomatic hypotension or systolic BP \<90 mmHg.
• −Evidence of intracardiac mass, thrombus, or vegetation.
• −Ebstein Anomaly or congenital right ventricular dysplasia.
• −Surgical or interventionalInterventional studyA study where participants are given something to see what happens.Read more → correction is indicated for other concomitant valvular diseases (subjects with concomitant valvular disease may treat their respective valve first and wait 30 days before being reassessed for the trial).
• −Subjects with valve prostheses implanted in the tricuspid valve.
• −Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction.
• −Active infection, infective endocarditis or sepsis within 3 months, or infections requiring antibiotics treatment within two weeks prior to planned procedure.
• −Untreated clinically significant coronary artery disease requiring revascularization.
• −Acute myocardial infarction or unstable ischemia-related angina within 30 days prior to the planned procedure.
• −Any percutaneous coronary, intracardiac or carotid intervention within 30 days prior to the planned procedure.
• −Cerebrovascular stroke (ischemic or bleeding) within 3 months prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
• −Active peptic ulcer or active gastrointestinal bleeding within 3 months prior to enrollment.
• −Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis, or coagulopathy.
• −Inability to tolerate anticoagulation or antiplatelet therapy.
• −Renal insufficiency (eGFR\< 30ml/min \[per the CKD-EPI formula\] and/or renal replacement therapy).
• −Patients with hepatic insufficiency or cirrhosis with Child-Pugh score class C
• −Severe Chronic Obstructive Pulmonary Disease requiring steroids or requiring continuous home oxygen.
• −Estimated life expectancy \<12 months.
• −Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpointPrimary endpointThe single main question the study is designed to answer.Read more →.
• −Subjects with current history of illicit drug use.
• −Any other condition making it unlikely the patient will be able to complete all protocolProtocolThe detailed plan a study must follow.Read more → procedure and follow-ups determined by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
• −Pregnancy or intent to become pregnant.