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The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B (PARTNERII B)

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ClinicalTrials.gov Identifier: NCT02184442
Recruitment Status : Completed
First Posted : July 9, 2014
Results First Posted : August 14, 2018
Last Update Posted : September 25, 2018
Sponsor:
Collaborator:
American College of Cardiology
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE January 17, 2014
First Posted Date  ICMJE July 9, 2014
Results First Submitted Date  ICMJE December 7, 2017
Results First Posted Date  ICMJE August 14, 2018
Last Update Posted Date September 25, 2018
Actual Study Start Date  ICMJE March 9, 2011
Actual Primary Completion Date May 1, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization [ Time Frame: 1 Year ]
All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
  • The clinical event of stroke [ Time Frame: 30 days ]
  • The clinical event of stroke [ Time Frame: 1 Year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
  • NYHA Classification - Change From Baseline [ Time Frame: Baseline and 1 Year ]
    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.
  • Total Aortic Regurgitation - Change From Baseline [ Time Frame: 1 Year ]
    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 one year was analyzed in the valve implant population.
  • Effective Orifice Area - Change From Baseline [ Time Frame: 1 Year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
VARC composite safety -Major vascular complications -Stroke [ Time Frame: 30 days and 1 year ]
  • VARC composite safety:
    • All cause mortality
    • Stroke
    • Life-threatening (or disabling) bleeding
    • Acute kidney injury - Stage 3 (including renal replacement therapy)
    • Peri-procedural MI
    • Repeat procedure for valve related dysfunction
  • Major vascular complications
  • Stroke
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
Official Title  ICMJE The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients
Brief Summary The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
Detailed Description

Cohort B was a 1:1 randomized, controlled study independently powered to compare transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in patients who could not undergo surgery (inoperable).

Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT THV with the associated delivery system.

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
  • Severe
  • Symptomatic
  • Calcific Aortic Stenosis
Intervention  ICMJE
  • Device: TAVR Implantation with SAPIEN XT
    Inoperable operable patients requiring the transcatheter aortic heart valve replacement
  • Device: TAVR Implantation with SAPIEN
    Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Study Arms  ICMJE
  • Experimental: TAVR - SAPIEN XT
    TAVR (transaortic valve replacement) with SAPIEN XT
    Intervention: Device: TAVR Implantation with SAPIEN XT
  • Active Comparator: TAVR - SAPIEN
    TAVR (transaortic valve replacement) with SAPIEN is the control arm
    Intervention: Device: TAVR Implantation with SAPIEN
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)
560
Original Actual Enrollment  ICMJE
 (submitted: July 8, 2014)
5000
Actual Study Completion Date  ICMJE May 30, 2017
Actual Primary Completion Date May 1, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
  2. The probability of death or serious, irreversible morbidity is greater than or equal to 50%.
  3. The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
  4. The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
  5. The study patient agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone follow-up.

Exclusion Criteria

  1. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
  2. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta. (Transfemoral)
  3. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
  4. It is known that the patient is currently enrolled in the PARTNER I Trial or was withdrawn from the PARTNER I Trial prior to endpoint analysis.
  5. Active bacterial endocarditis within 6 months (180 days) of procedure.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 NCT02184442
Other Study ID Numbers  ICMJE 2010-12-PIIB
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
Responsible Party Edwards Lifesciences
Study Sponsor  ICMJE Edwards Lifesciences
Collaborators  ICMJE American College of Cardiology
Investigators  ICMJE
Principal Investigator: Martin B Leon, MD Columbia University
PRS Account Edwards Lifesciences
Verification Date August 2018

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