Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device Short Title: TRISCEND II Pivotal Trial

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Severe Tricuspid Regurgitation.
Age: Between 18 Year(s) - 100 Year(s)
Gender: Male or Female

Other Inclusion Criteria:
1. Despite medical therapy (OMT) per the local Heart Team, patient has signs of tricuspid regurgitation (TR), symptoms from TR, or prior heart failure hospitalization from TR
2. Functional and/or degenerative TR graded as at least severe on a transthoracic echocardiogram (assessed by the echo core lab using a 5-grade classification)3
3. The Local Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement
4. Willing and able to comply with all study evaluations and provides written informed consent

You may not be eligible for this study if the following are true:

1. Tricuspid valve anatomy precluding proper device deployment and function
2. Echocardiographic parameters as listed in the protocol
3. Previous tricuspid surgery or intervention that could interfere with placement of the EVOQUE System
4. Presence of trans-tricuspid pacemaker or defibrillator lead:
  - Implanted in the RV within the last 3 months prior to randomization
  - Patient is pacemaker dependent5 on trans-tricuspid lead without alternative pacing option
5. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation.
6. Active endocarditis within 3 months of randomization or infection requiring antibiotic therapy
7. Hemodynamically significant pericardial effusion
8. Significant intra-cardiac mass, thrombus, or vegetation
9. Clinically significant, untreated coronary artery disease requiring revascularization, evidence of acute coronary syndrome, recent myocardial infarction
10. Any percutaneous coronary, intracardiac carotid, endovascular intervention, carotid surgery, leadless RV pacemaker implant within 30 days OR cardiac surgery within 90 days prior to randomization
11. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
12. Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intraaortic balloon pump or other hemodynamic support device within 30 days of randomization

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