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PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk (PII A)

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: NCT01314313
Recruitment Status : Active, not recruiting
First Posted : March 14, 2011
Results First Posted : August 14, 2018
Last Update Posted : August 31, 2022
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 XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

Condition or disease Intervention/treatment Phase
Symptomatic Severe Aortic Stenosis Device: TAVR Implantation with SAPIEN XT Device: SAVR Implantation Not Applicable

Detailed Description:

The PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control arm will receive a surgical bioprosthetic heart valve via aortic valve replacement surgery.

To assure that patients with an STS score ≥ 4% have been selected.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2032 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Intermediate and High Risk Patients
Actual Study Start Date : March 2011
Actual Primary Completion Date : January 2016
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PIIA - SAPIEN XT
PIIA is operable group
 Device: TAVR Implantation with SAPIEN XT
Operable Group with SAPIEN XT
Active Comparator: Control: SAVR
SAVR (surgical aortic valve replacement) is the control arm
 Device: SAVR Implantation
Control Group


Outcome Measures
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Primary Outcome Measures :
  1. All-cause Death or Disabling Stroke to Two Years [ Time Frame: 2 Years ]
    All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)


Secondary Outcome Measures :
  1. Adjusted Days Alive and Out of Hospital (DAOH) to Two Years [ Time Frame: 2 years ]
    The number of days the patients are alive and out of the hospital.

  2. Total Aortic Regurgitation (AR) at 2 Years [ Time Frame: 2 years ]
    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 two year was analyzed in the valve implant population.

  3. 6MWT Change From Baseline [ Time Frame: Baseline and 2 years ]
    Six Minute Walk Test change from baseline to 2 years

  4. NYHA Classification at 2 Years [ Time Frame: 2 years ]
    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.

  5. Effective Orifice Area (EOA) [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, 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. Study patient agrees to undergo surgical aortic valve replacement (SAVR) - if randomized to control treatment.

Exclusion Criteria

  1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
  2. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
  3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
  4. Preexisting mechanical or bioprosthetic valve in any position (except NR3).
  5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD (S3 Cohort only) is not excluded.
  6. Heart team assessment of inoperability (including examining cardiac surgeon).
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): NCT01314313


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: NCT01314313    
Other Study ID Numbers: 2010-12 PIIA
First Posted: March 14, 2011    Key Record Dates
Results First Posted: August 14, 2018
Last Update Posted: August 31, 2022
Last Verified: August 2022
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 XT
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