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Completed

NCT Number: NCT02184442

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

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.

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Key information

Conditions

Severe Aortic Valve Disease Aortic Valve Stenosis Aortic Valve, Calcification of Calcific Aortic Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Symptomatic Ventricular Outflow Obstruction

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Heart Hospital/Clinic, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
  • The probability of death or serious, irreversible morbidity is greater than or equal to 50%.
  • The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
  • 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.
  • 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

  • Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
  • 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)
  • 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.
  • 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.
  • Active bacterial endocarditis within 6 months (180 days) of procedure.

Treatment and study plan

TAVR Implantation with SAPIEN XT

Device

Inoperable operable patients requiring the transcatheter aortic heart valve replacement

TAVR Implantation with SAPIEN

Device

Inoperable operable patients requiring the transcatheter aortic heart valve replacement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Collaborators

  • American College of Cardiology

Registry information

Official study title

The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients

Acronym: PARTNERII B

Important dates

Study start
2011
Primary completion
2013
Study completion
2017
First posted
Jul 9, 2014
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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