PARTNER II Trial: S3iCAP

Study Overview
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Brief Summary
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Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.

Detailed Description
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This multi-center, single arm registry will provide continued access of the Edwards SAPIEN 3 Transcatheter Heart Valve and delivery systems to severe aortic stenosis patients at intermediate risk for standard aortic valve replacement. Patient data will be entered into the TVT Registry (TVTR) from screening through 1 year including the collection of 5 year follow-up through CMS.

Official Title
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The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves: Continued Access Program for SAPIEN 3 Intermediate Risk (S3iCAP)

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Device: SAPIEN S3 valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be covered by Medicare. This will enable Edwards to link to the CMS database for long term follow-up through 5 years. No other insurance provider will be accepted. Assessment of intermediate surgical risk defined as STS 4-8% or heart team assessment of intermediate risk factors. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient > 40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of < 0.8 cm2 or indexed EOA < 0.5 cm2/m2. Qualifying echo must be within 60 days of the date of the procedure. Aortic valve annulus area range (273mm2-680 mm2) per 3D imaging (echo, CT, or MRI). Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient. Heart team agrees (a priori) on treatment strategy for concomitant coronary disease (if present). The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up. Exclusion Criteria: Heart team assessment of inoperability (including examining cardiac surgeon). 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)]. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified. Mixed aortic valve disease (aortic stenosis and aortic re-regurgitation with predominant aortic regurgitation >3+). Pre-existing mechanical or bioprosthetic valve in any position. Complex coronary artery disease: Unprotected left main coronary artery Syntax score > 32 (in the absence of prior revascularization) Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD is not considered exclusion criteria. Any patient with a balloon valvuloplasty (BAV) < 30 days of the procedure (unless BAV is a bridge to procedure after a qualifying ECHO). Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation. Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), thrombocytopenia (Plt < 50,000 cell/mL). Hypertrophic cardiomyopathy with or without obstruction (HOCM). Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation. Need for emergency surgery for any reason. Severe ventricular dysfunction with LVEF < 20%. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. Active upper GI bleeding within 3 months (90 days) prior to procedure. A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure. Native aortic annulus size < 16 mm or > 28mm as measured by echocardiogram. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure. Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening. Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal dis-ease or chronic end stage pulmonary disease. Expectation that patient will not improve despite treatment of aortic stenosis. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe unfolding and tortuosity of the thoracic aorta. (Transfemoral) Iliofemoral vessel characteristics that would preclude safe placement of 14F or 16F introducer sheath such as severe obstructive calcification, severe tortuosity or min-imum average vessel size less than 5.5 mm. (Transfem-oral). Currently participating in an investigational drug or an-other device study. Note: Trials requiring extended fol-low-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Active bacterial endocarditis within 6 months (180 days) of procedure. Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis. Inability to tolerate anticoagulation/antiplatelet therapy. For transfemoral approach only: Femoro-iliac vessels < 5.5 mm for the 23 mm and the 26 mm system and < 6.0 mm for the 29 mm system.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAVR<br>Intermediate risk patients receiving transcatheter aortic valve replacement (TAVR) | Device: SAPIEN S3 valve<br>* Transcatheter aortic valve replacement<br>* Other names: SAPIEN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Number of deaths | 30 days | 
| Death | Number of deaths | 1 year | 
| Stroke | Number of participants with stroke | 30 days | 
| Stroke | Number of participants with stroke | 1 year | 
| Aortic Valve Reintervention | Number of participants with aortic valve reintervention | 30 days | 
| Aortic Valve Reintervention | Number of participants with aortic valve reintervention | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annular Dissection | Number of participants with annular dissection | 30 days | 
| Aortic Dissection | Number of participants with aortic dissection | 30 days | 
| Major Access Vascular Site Complication | Number of participants with major vascular complications | 30 days | 
| Unplanned Vascular Surgery or Intervention | Number of participants with unplanned vascular surgery or intervention | 30 days | 
| Retroperitoneal Bleeds | Number of participants with retroperitoneal bleed | 30 days | 
| Gastrointestinal Bleed | Number of participants with gastrointestinal bleeding | 30 days | 
| Genitourinary Bleed | Number of participants with genitourinary bleeding | 30 days | 
| Bleeding at Access Site | Number of participants with bleeding at the access site | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S3iCAP, SAPIEN 3, Transfemoral, Commander, Certitude, TAVR, TAVI, Aortic stenosis, THV, Transcatheter Heart Valve, TVT, TVTR