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

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: 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

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients
Actual Study Start Date : March 9, 2011
Actual Primary Completion Date : May 1, 2013
Actual Study Completion Date : May 30, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TAVR - SAPIEN XT
TAVR (transaortic valve replacement) with SAPIEN XT
 Device: TAVR Implantation with SAPIEN XT
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Active Comparator: TAVR - SAPIEN
TAVR (transaortic valve replacement) with SAPIEN is the control arm
 Device: TAVR Implantation with SAPIEN
Inoperable operable patients requiring the transcatheter aortic heart valve replacement


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.


  3. Effective Orifice Area - Change From Baseline [ Time Frame: 1 Year ]

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 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.
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): NCT02184442


Locations
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Sponsors and Collaborators
Edwards Lifesciences
American College of Cardiology
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: NCT02184442    
Other Study ID Numbers: 2010-12-PIIB
First Posted: July 9, 2014    Key Record Dates
Results First Posted: August 14, 2018
Last Update Posted: September 25, 2018
Last Verified: August 2018
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
TAVR
THV
Aortic Stenosis
 Heart Valve Disease
Aortic Valve
Retroflex
SAPIEN XT
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction