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

Calcific Aortic Stenosis Clinical Trial

— PARTNERII B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184442
• Other study ID #: 2010-12-PIIB
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Calcific Aortic Stenosis
• Calcinosis
• Severe
• Symptomatic

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