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

Not Applicable

Completed

• Conditions: Severe; Symptomatic; Calcific Aortic Stenosis

• Registration Number: NCT02184442
• Lead Sponsor: Edwards Lifesciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-03-09
• Primary Completion: 2013-05-01
• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-09
• Study Completion: 2017-05-30
• Results First Submitted: 2017-12-07
• Results First Submitted QC: 2018-07-17
• Status Verified: 2018-08
• Results First Posted: 2018-08-14
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization	1 Year	All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year

Secondary Outcome Measures

Name	Time	Method
NYHA Classification - Change From Baseline	Baseline and 1 Year	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.
Total Aortic Regurgitation - Change From Baseline	1 Year	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.
Effective Orifice Area - Change From Baseline	1 Year

Trial Locations

Locations (53)

Arkansas Heart Hospital/Clinic; 🇺🇸 Little Rock, Arkansas, United States

Scripps Green Hospital; 🇺🇸 La Jolla, California, United States

Scripps Memorial Hospital; 🇺🇸 La Jolla, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Mercy General Hospital; 🇺🇸 Sacramento, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

University of Colorado Hospital; 🇺🇸 Denver, Colorado, United States

Washington Hospital Center (WHC); 🇺🇸 Washington, District of Columbia, United States

Morton Plant Hospital; 🇺🇸 Clearwater, Florida, United States

University of Florida, Gainesville; 🇺🇸 Gainesville, Florida, United States

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