ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation

A vizsgálat adatai

Ki végzi

Abbott Medical Devices

Azonosító

NCT05932615

A regiszteradat frissítve

2026. szeptember 11.

Eredeti leírás

The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.A teljes eredeti leírásKevesebb

Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients Who Have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement

The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.

The trial will also evaluate the safety and effectiveness of the Navitor TAVI System in a valve-in-valve (ViV) application in patients with symptomatic heart disease due to failure of a surgical or transcatheter bioprosthetic aortic valve who are at high or greater surgical risk.

In addition, the trial will assess the safety of the Navitor TAVI System for the treatment of symptomatic, severe native aortic stenosis in patients with bicuspid aortic valve anatomy, irrespective of surgical risk classification.

Bevonási feltételek: Subject who is deemed to be at intermediate or low risk for open surgical aortic valve replacement:; Intermediate risk: estimated risk of overall surgical mortality ≥ 3% and < 8% at 30 days; Low risk: estimated risk of overall surgical mortality < 3% at 30 days Estimated risk of overall surgical mortality includes consideration of the Society of Thoracic Surgeons (STS) risk score, overall clinical status, and other clinical co-morbidities unmeasured by the risk calculator; New York Heart Association (NYHA) Functional Classification of II, III, or IV; Degenerative aortic valve stenosis.

Kizáró feltételek: Evidence of an acute myocardial infarction [defined as ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) with acute ischemia symptoms and troponin elevation] within 30 days prior to index procedure; Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior (except pacemaker or implantable cardioverter defibrillator (ICD) implant) to index procedure or planned within 30 days following the index procedure; Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation; Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA); Hostile chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk (i.e., mediastinitis, radiation damage, abnormal chest wall, porcelain aorta, adhesion of aorta or internal mammary artery to sternum, etc.); Hostile Chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk; Untreated clinically significant coronary artery disease requiring revascularization; Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk; Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+); Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position; Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk; Mixed aortic valve disease; Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position; Additional Exclusion Criteria for ViV Cohort; Patient has a pre-existing prosthetic heart valve or other implant (such a prosthetic ring with a rigid support structure or transcatheter edge-to-edge repair clip) in any valve position other than aortic; Blood dyscrasias as defined: leukopenia (WBC < 3000 mm3), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count < 50,000 cells/mm³); history of bleeding diathesis or coagulopathy; Renal insufficiency (creatinine > 3.0 mg/dL or eGFR < 30 ml/min/1.73m2) and/or end stage renal disease requiring chronic dialysis; Severe ventricular dysfunction with LVEF < 30% as measured by resting echocardiogram; Severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT); In the opinion of the Investigator, life expectancy is less than 2 years; Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT; Severe (greater than or equal to 3+) mitral regurgitation or severe mitral stenosis; Minimum access vessel diameter of < 5.0 mm for small FlexNav Delivery System and < 5.5 mm for large FlexNav Delivery System; Eccentricity ratio of the annulus < 0.73; Additional Exclusion Criteria for Pivotal Randomized Cohort; Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT; Inadequate aortic valve calcification; Failing valve has moderate or greater paravalvular regurgitation; Known severe prosthesis-patient mismatch; Failing valve is unstable, rocking, or not structurally intact; Bioprosthetic valve diameter that would not accommodate implantation of the Navitor Valve; Increased risk of coronary obstruction by prosthetic leaflets of the index valve; Additional Exclusion Criteria for bicuspid cohort; In the opinion of the Investigator life expectancy is less than 1 year; Inadequate or severe aortic valve calcification and/or anatomical features that would preclude safe delivery of the valve.

ClinicalTrials.gov NCT05932615