PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve

Aortic Stenosis Clinical Trial

— PII NR3/ViV  

Official title:

Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Patients With a Failing Aortic Bioprosthetic Valve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225001
• Other study ID #: 2010-12 NR3/ViV
• Status: Completed
• Phase: N/A
• Start date: June 11, 2012
• Est. completion date: October 28, 2020

Study information

• Verified date: February 2021
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.

Description:

A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency. This is a PARTNER II nested registry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: October 28, 2020
• Est. primary completion date: December 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of =0.8 cm2 or indexed EOA < 0.5 cm2/m2. Qualifying echo must be within 60 days of the date of the procedure.

2. Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.

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. Heart team consensus that the risk of surgical mortality or major morbidity = 50%.

6. Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic position.

Exclusion Criteria:

1. Bioprosthetic valve labeled external diameter < 21mm.

2. Surgical or transcatheter valve in another position on the same side of the heart (mitral and tricuspid rings are not an exclusion).

3. Infectious endocarditis within 6 months.

4. Acute myocardial infarction = 1 month (30 days) before the intended treatment.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Cardiomyopathies
• Cardiomyopathy, Hypertrophic

Intervention

Device:
• Edwards SAPIEN XT transcatheter valve, Model 9300TFX
Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.

Locations

Country	Name	City	State
Canada	St. Paul's Hospital, Providence Health Care	Vancouver	British Columbia
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern Hospital	Chicago	Illinois
United States	The Christ Hospital	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	NorthShore University HealthSystem Research Institute	Evanston	Illinois
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	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	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	University of Miami	Miami	Florida
United States	Winthrop-University Hospital	Mineola	New York
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University Medical Center/ New York Presbyterian Hospital	New York	New York
United States	Cornell University	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Providence St.Vincent Medical Center	Portland	Oregon
United States	Mayo Clinic-Saint Marys Hospital	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	Intermountain Medical Center	Salt Lake City	Utah
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

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)	The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak	30-day
Secondary	Number of Participants With Mortality From Any Cause	Cardiovascular cause is also included	30 Days