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PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7 (PII S3HR/NR7)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03222141
Recruitment Status : Completed
First Posted : July 19, 2017
Results First Posted : August 14, 2018
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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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, severe aortic stenosis, and are in high risk.

Condition or disease Intervention/treatment Phase
Symptomatic Severe Aortic Stenosis Device: TAVR Implantation of the THV Prosthesis Not Applicable

Detailed Description:
This is a prospective, non-randomized, multi-center trial for patients undergoing aortic valve replacement with the Edwards SAPIEN 3 THV for severe aortic stenosis. Patient cohorts will include those inoperable and those considered as a high surgical risk (STS ≥8%). The study also includes NR7 patients (patients with a 20mm vessel size).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 583 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Edwards SAPIEN 3 Transcatheter Heart Valve Therapy for High Risk and Inoperable Patients
Actual Study Start Date : October 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : August 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: SAPIEN 3™ valve Device: TAVR Implantation of the THV Prosthesis
Patients with TAVR implantation
Other Name: SAPIEN 3™valve


Outcome Measures
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Primary Outcome Measures :
  1. The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate [ Time Frame: 30 Days ]
    The composite rate of all-cause mortality, all stroke, and AI ≥ moderate for patients deemed as 'high risk' using the Edwards SAPIEN 3 transcatheter heart valve (THV).


Secondary Outcome Measures :
  1. Number of Participants With Major Vascular Complications [ Time Frame: 30 Days ]
    The rate of major vascular complications at 30 days post implantation

  2. Number of Participants With Aortic Insufficiency at 30 Days [ Time Frame: 30 Days ]
    The proportion of patients with aortic insufficiency ≥ moderate at 30 days.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
  3. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
  4. 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.
  5. 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.
  6. STS > 8

Exclusion Criteria:

  1. Pre-existing mechanical or bioprosthetic valve in any position.
  2. Active bacterial endocarditis within 6 months (180 days) of procedure.
  3. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  4. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure. Implantation of a permanent pacemaker or ICD is not considered exclusion criteria.
  5. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222141


Locations
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Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Martin B Leon, MD Columbia University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03222141    
Other Study ID Numbers: 2010-12 S3HR/NR7
First Posted: July 19, 2017    Key Record Dates
Results First Posted: August 14, 2018
Last Update Posted: May 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Edwards Lifesciences:
SAPIEN 3
Transfemoral
Transapical
Transaortic
TAVI
 Aortic Stenosis
THV
Aortic Valve
Transcatheter Heart Valve
TAVR
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction