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PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate (PII S3i)

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: NCT03222128
Recruitment Status : Active, not recruiting
First Posted : July 19, 2017
Results First Posted : August 14, 2018
Last Update Posted : November 30, 2023
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, and severe aortic stenosis, and those with intermediate risk.

Condition or disease Intervention/treatment Phase
Symptomatic Severe Aortic Stenosis Device: TAVR Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1074 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 Intermediate Risk Patients
Actual Study Start Date : February 17, 2014
Actual Primary Completion Date : November 18, 2015
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PIIS3i - SAPIEN 3
PIIS3i - SAPIEN 3 is Operable Group
 Device: TAVR
Implantation of the SAPIEN 3


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days [ Time Frame: 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.

Exclusion Criteria:

  1. Heart team assessment of inoperability (including examining cardiac surgeon).

  2. Complex coronary artery disease

    1. Unprotected left main coronary artery
    2. Syntax score > 32 (in the absence of prior revascularization)
  3. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of screening evaluation.
  4. Need for emergency surgery for any reason.
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): NCT03222128


Locations
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Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Martin B Leon, MD Columbia University
Principal Investigator: Craig Smith, 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: NCT03222128    
Other Study ID Numbers: 2010-12 PIIS3i
First Posted: July 19, 2017    Key Record Dates
Results First Posted: August 14, 2018
Last Update Posted: November 30, 2023
Last Verified: November 2023
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
NovaFlex
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