The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.

Detailed Description
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Cohort B was a 1:1 randomized, controlled study independently powered to compare transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in patients who could not undergo surgery (inoperable). Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT THV with the associated delivery system.

Official Title
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The PARTNER II Trial Placement of AoRTic TraNscathetER Valves Trial (US) [PII B] for Inoperable Patients

Conditions
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Severe, Symptomatic, Calcific Aortic Stenosis

Intervention / Treatment
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* Device: TAVR Implantation with SAPIEN XT
* Device: TAVR Implantation with SAPIEN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater. The probability of death or serious, irreversible morbidity is greater than or equal to 50%. The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient. The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. The study patient agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone follow-up. Exclusion Criteria Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified. 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) Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. It is known that the patient is currently enrolled in the PARTNER I Trial or was withdrawn from the PARTNER I Trial prior to endpoint analysis. Active bacterial endocarditis within 6 months (180 days) of procedure.

Ages Eligible for Study
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Minimum Age: 19 Years

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAVR - SAPIEN XT<br>TAVR (transaortic valve replacement) with SAPIEN XT | Device: TAVR Implantation with SAPIEN XT<br>* Inoperable operable patients requiring the transcatheter aortic heart valve replacement<br>|
| Active Comparator: TAVR - SAPIEN<br>TAVR (transaortic valve replacement) with SAPIEN is the control arm | Device: TAVR Implantation with SAPIEN<br>* Inoperable operable patients requiring the transcatheter aortic heart valve replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization | All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA Classification - Change From Baseline | New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort. | Baseline and 1 Year | 
| Total Aortic Regurgitation - Change From Baseline | Total aortic regurgitation was assessed by the core lab as 'Grade 0' = None, 'Grade 1+' = Trace, 'Grade 2+' = Mild, 'Grade 3+' = Moderate, and 'Grade 4+' = Severe. Total regurgitation at one year was analyzed in the valve implant population. | 1 Year | 
| Effective Orifice Area - Change From Baseline |  | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SAPIEN, TAVR, THV, Aortic Stenosis, Heart Valve Disease, Aortic Valve, Retroflex, SAPIEN XT