Philadelphia, Pennsylvania 19140


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: 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 requiring diuretics.) 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. Exclusion Criteria: 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 definition)]. 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 heart catheterization. 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 Fibrillation. 7. Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/mL). 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 regurgitation 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.


NCT ID:

NCT02339974


Primary Contact:

Principal Investigator
Brian P O'Neill, MD
Temple University

Jennie Wong, RN BSN CCRP
Phone: 215-707-5340
Email: Jennie.Wong@tuhs.temple.edu


Backup Contact:

Email: Brian.O'Neill@tuhs.temple.edu
Brian O'Neill, MD
Phone: 215-707-2230


Location Contact:

Philadelphia, Pennsylvania 19140
United States

Jennie Wong, RN BSN CCRP
Phone: 215-707-5340

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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