The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Completed
First Posted : March 14, 2011
Results First Posted : August 14, 2018
Last Update Posted : March 7, 2024
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE March 7, 2011
First Posted Date  ICMJE March 14, 2011
Results First Submitted Date  ICMJE September 16, 2016
Results First Posted Date  ICMJE August 14, 2018
Last Update Posted Date March 7, 2024
Actual Study Start Date  ICMJE March 2011
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2018)		 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)
Original Primary Outcome Measures  ICMJE
 (submitted: March 10, 2011)		 Time to death, major stroke and repeat hospitalization assessed at 1 year [ Time Frame: 1 Year ]
A non-hierarchical composite; primary endpoint composed of time to 1) death, and 2) major stroke, and 3) repeat hospitalization (for valve-related decompensation or procedure-related complications)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
  • 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.
  • 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.
  • 6MWT Change From Baseline [ Time Frame: Baseline and 2 years ]
    Six Minute Walk Test change from baseline to 2 years
  • 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.
  • Effective Orifice Area (EOA) [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2011)		 Freedom from other secondary events assessed at 30 days, 6 months and 1 year [ Time Frame: 30 days, 6 month, and 1 year ]
Freedom from Stroke/MI/Major Bleeding/Acuter Renal Injury/Major Vascular Complication/Valve Related Complication/Aortic PVL/Severe Conduction Defect
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 - XT Intermediate and High Risk
Official Title  ICMJE Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Intermediate and High Risk Patients
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Symptomatic Severe Aortic Stenosis
Intervention  ICMJE
  • Device: TAVR Implantation with SAPIEN XT
    Operable Group with SAPIEN XT
  • Device: SAVR Implantation
    Control Group
Study Arms  ICMJE
  • Experimental: PIIA - SAPIEN XT
    PIIA is operable group
    Intervention: Device: TAVR Implantation with SAPIEN XT
  • Active Comparator: Control: SAVR
    SAVR (surgical aortic valve replacement) is the control arm
    Intervention: Device: SAVR Implantation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2018)		 2032
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2011)		 600
Actual Study Completion Date  ICMJE January 17, 2024
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, 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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01314313
Other Study ID Numbers  ICMJE 2010-12 PIIA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Edwards Lifesciences
Original Responsible Party Jodi Akin, Vice President, Clinical Affairs, Edwards Lifesciences LLC
Current Study Sponsor  ICMJE Edwards Lifesciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin B Leon, MD Columbia University
Principal Investigator: Craig Smith, MD Columbia University
PRS Account Edwards Lifesciences
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP