PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate (PII S3i)
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ClinicalTrials.gov Identifier: NCT03222128 |
Recruitment Status :
Active, not recruiting
First Posted : July 19, 2017
Results First Posted : August 14, 2018
Last Update Posted : November 30, 2023
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Sponsor:
Edwards Lifesciences
Information provided by (Responsible Party):
Edwards Lifesciences
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Tracking Information | |||||||
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First Submitted Date ICMJE | July 17, 2017 | ||||||
First Posted Date ICMJE | July 19, 2017 | ||||||
Results First Submitted Date ICMJE | December 7, 2017 | ||||||
Results First Posted Date ICMJE | August 14, 2018 | ||||||
Last Update Posted Date | November 30, 2023 | ||||||
Actual Study Start Date ICMJE | February 17, 2014 | ||||||
Actual Primary Completion Date | November 18, 2015 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate [ Time Frame: 1 year ] | ||||||
Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days [ Time Frame: 30 Days ] | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate | ||||||
Official Title ICMJE | Edwards SAPIEN 3 Transcatheter Heart Valve Therapy for Intermediate Risk Patients | ||||||
Brief Summary | The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk. | ||||||
Detailed Description | This study design consists of PIIS3i cohort. The PIIS3i cohort is a single arm non-randomized, historical-controlled study. Patients recruited to the treatment arm will receive an Edwards SAPIEN 3 THV with either transfemoral, transapical or transaortic delivery access. To ensure that patients are of "intermediate" risk, an STS score of 4 - 8% has been selected. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Symptomatic Severe Aortic Stenosis | ||||||
Intervention ICMJE | Device: TAVR
Implantation of the SAPIEN 3
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Study Arms ICMJE | Experimental: PIIS3i - SAPIEN 3
PIIS3i - SAPIEN 3 is Operable Group
Intervention: Device: TAVR
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
1074 | ||||||
Original Actual Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | November 2025 | ||||||
Actual Primary Completion Date | November 18, 2015 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03222128 | ||||||
Other Study ID Numbers ICMJE | 2010-12 PIIS3i | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Edwards Lifesciences | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Edwards Lifesciences | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Edwards Lifesciences | ||||||
Verification Date | November 2023 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |