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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02184442
Other study ID # 2010-12-PIIB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 9, 2011
Est. completion date May 30, 2017

Study information

Verified date August 2018
Source Edwards Lifesciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 560
Est. completion date May 30, 2017
Est. primary completion date May 1, 2013
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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.

Study Design


Intervention

Device:
TAVR Implantation with SAPIEN XT
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
TAVR Implantation with SAPIEN
Inoperable operable patients requiring the transcatheter aortic heart valve replacement

Locations

Country Name City State
United States Emory University Hospital Atlanta Georgia
United States Austin Heart, PLLC Austin Texas
United States University of Maryland Medical Center Baltimore Maryland
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Medical University of South Carolina Charleston Charleston North Carolina
United States University of Virginia Charlottesville Virginia
United States Northwestern Hospital Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States The Christ Hospital, Cincinnati Cincinnati Ohio
United States Morton Plant Hospital Clearwater Florida
United States Cleveland Clinic Foundation Cleveland Ohio
United States Medical City Dallas Hospital Dallas Texas
United States The Heart Hospital Baylor Plano Dallas Texas
United States University of Colorado Hospital Denver Colorado
United States Henry Ford Hospital Detroit Michigan
United States University of Florida, Gainesville Gainesville Florida
United States East Carolina Heart Institute at East Carolina University Greenville North Carolina
United States The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center Houston Texas
United States Indiana University Health-Methodist Hospital Indianapolis Indiana
United States The University of Iowa Iowa City Iowa
United States Saint Luke's Hospital of Kansas City Mid America Kansas City Missouri
United States Scripps Green Hospital La Jolla California
United States Scripps Memorial Hospital La Jolla California
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Nebraska Heart Institute Lincoln Nebraska
United States Arkansas Heart Hospital/Clinic Little Rock Arkansas
United States Cedars-Sinai Medical Center Los Angeles California
United States University of Louisville - Jewish Hospital Louisville Kentucky
United States University of Wisconsin - Madison Madison Wisconsin
United States North Shore University Hospital, NY Manhasset New York
United States Baptist Memorial Hospital Memphis Tennessee
United States University of Miami Miami Florida
United States Winthrop University Hospital Mineola New York
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota
United States Intermountain Medical Center Murray Utah
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Columbia University Medical Center New York New York
United States Cornell University New York New York
United States Newark Beth Israel Newark New Jersey
United States Sentara Norfolk General Hospital Norfolk Virginia
United States Oklahoma Heart Hospital Oklahoma City Oklahoma
United States University of Pennsylvania Hospital Philadelphia Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States William Beaumont Hospital Royal Oak Michigan
United States Mercy General Hospital Sacramento California
United States Washington University - Barnes Jewish Hospital Saint Louis Missouri
United States University of Texas Health Science Center at San Antonio (UTHSCSA) San Antonio Texas
United States University of Washington Seattle Washington
United States Prairie Education and Research Cooperative Springfield Illinois
United States Stanford University Medical Center Stanford California
United States Washington Hospital Center (WHC) Washington District of Columbia
United States York Hospital York Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Edwards Lifesciences American College of Cardiology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year 1 Year
Secondary NYHA Classification - Change From Baseline 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. Baseline and 1 Year
Secondary Total Aortic Regurgitation - Change From Baseline 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.
1 Year
Secondary Effective Orifice Area - Change From Baseline 1 Year
See also
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Completed NCT02132026 - Study Investigating the Effect of Drugs Used to Treat Osteoporosis on the Progression of Calcific Aortic Stenosis. Phase 2