The goal of this study is to determine the short term safety (<30 days) and efficacy (6
months) of the heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena
cava for the treatment of severe tricuspid regurgitation in patients who are inoperable or
at a very high surgical risk for tricuspid valve replacement.
This is a prospective multi-center, non-blinded (open label), non-randomized safety and
feasibility study of the heterotopic implantation of the Edwards-Sapien XT or S3 valve in
the inferior vena cava for the treatment of severe tricuspid regurgitation in patients who
are inoperable or at a very high surgical risk for tricuspid valve replacement.
1. Patients must be at least 21 years old.
2. The patient must have severe, symptomatic (ACC/AHA Stage D symptoms) tricuspid
regurgitation (TR) as assessed by 2D echocardiogram with evidence of peripheral and
central venous congestion (specifically lower extremity edema and abdominal ascites
3. The patient must be evaluated by a "heart team" of physicians including an
interventional cardiologist, cardiothoracic surgeon, heart failure specialist, and
imaging specialist, and presented for review at a local multi-disciplinary
conference. By consensus, the heart team must agree (and verify in the case review
process) that valve implantation will likely benefit the patient.
4. The heart team must agree that medical factors preclude operation, based on a
conclusion that the probability of death or serious, irreversible morbidity exceeds
the probability of meaningful improvement. Also, other factors which may increase the
patients perceived surgical risk for inclusion in the trial will be clearly
delineated if they are present. These include, but are not limited to the following
as defined by VARC 2: Frailty, Hostile chest, porcelain aorta, IMA or other critical
conduit crossing the midline or adherent to the posterior table of sternum, severe
right ventricular (RV) dysfunction. The surgeons' consultation notes shall specify
the medical or anatomic factors leading to that conclusion. At least one of the
cardiac surgeon assessors must have interviewed and examined the patient.
5. The study patient provides informed consent and agrees to comply with all required
post-procedure follow-up visits, including annual visits up to 5 years.
1. Heart Team assessment of operability (the heart team considers the patient to be a
good surgical candidate).
2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended
treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥
twice normal in the presence of MB elevation and/or troponin level elevation (WHO
3. Untreated, severe, left sided valvular heart disease including mitral regurgitation
or stenosis, and aortic regurgitation or stenosis.
4. Mean pulmonary artery pressures ≥40mmHG and PVR >4 woods units as assessed by right
5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is
performed within 30 days of the index procedure. Examples of permanent implant would
include any new heart valve. Implantation of a permanent pacemaker is excluded.
6. Patients with planned concomitant surgical or transcatheter ablation for Atrial
7. Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt <
8. Hemodynamic or respiratory instability requiring inotropic support, mechanical
ventilation or mechanical heart assistance within 30 days of screening evaluation.
9. Need for emergency surgery for any reason.
10. Left ventricular ejection fraction <40%.
11. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
12. Active upper GI bleeding within 3 months (90 days) prior to procedure.
13. A known contraindication or hypersensitivity to all anticoagulation regimens, or
inability to be anticoagulated for the study procedure.
14. Recent CVA clinically confirmed (by neurologist) or neuroimaging confirmed stroke or
transient ischemic attack (TIA) within 6 months (180 days) of the procedure.
15. Estimated life expectancy < 1 year from conditions other than TR.
16. Expectation that patient will not improve despite treatment of tricuspid
17. Currently participating in another investigational cardiac device study or any other
clinical trial, including drugs or biologics. Note: Trials requiring extended
follow-up for products that were investigational, but have since become commercially
available, are not considered investigational trials.
18. Active bacterial endocarditis within 6 months (180 days) of procedure.
19. Patients with signs or symptoms of SVC syndrome, or hepatic cirrhosis not felt due to
passive congestion from TR.
20: Subject unable to personally provide informed consent 21. FEV1<30% of predicted 22.
Model for End State Liver Disease (MELD) score ≥21 (calculated per reference study.