PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7

Symptomatic Severe Aortic Stenosis Clinical Trial

— PII S3HR/NR7  

Official title:

Edwards SAPIEN 3 Transcatheter Heart Valve Therapy for High Risk and Inoperable Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03222141
• Other study ID #: 2010-12 S3HR/NR7
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: August 2020

Study information

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

Clinical Trial Summary

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis, and are in high risk.

Description:

This is a prospective, non-randomized, multi-center trial for patients undergoing aortic valve replacement with the Edwards SAPIEN 3 THV for severe aortic stenosis. Patient cohorts will include those inoperable and those considered as a high surgical risk (STS ≥8%). The study also includes NR7 patients (patients with a 20mm vessel size).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 583
• Est. completion date: August 2020
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years 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 is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.

3. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.

4. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

5. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.

6. STS > 8

Exclusion Criteria:

1. Pre-existing mechanical or bioprosthetic valve in any position.

2. Active bacterial endocarditis within 6 months (180 days) of procedure.

3. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.

4. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure. Implantation of a permanent pacemaker or ICD is not considered exclusion criteria.

5. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Symptomatic Severe Aortic Stenosis

Intervention

Device:
• TAVR Implantation of the THV Prosthesis
Patients with TAVR implantation

Locations

Country	Name	City	State
Canada	St. Paul's Hospital, Providence Health Care	Vancouver	British Columbia
United States	Emory University	Atlanta	Georgia
United States	Austin Heart, PLLC	Austin	Texas
United States	MedStar Union Memorial Hospital	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
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	Ohio
United States	Morton Plant Hospital	Clearwater	Florida
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Medical City Dallas	Dallas	Texas
United States	University of Colorado Hospital	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Indiana University Health-Methodist Hospital	Indianapolis	Indiana
United States	The University of Iowa	Iowa City	Iowa
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Cedars-Sinai Medical Center	Los Angeles	California
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 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	The Heart Hospital Baylor Plano	Plano	Texas
United States	Providence St.Vincent Medical Center	Portland	Oregon
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 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 DC	Washington	District of Columbia
United States	York Hospital	York	Pennsylvania

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	The Composite Rate of All-cause Mortality, All Stroke, and AI = Moderate	The composite rate of all-cause mortality, all stroke, and AI = moderate for patients deemed as 'high risk' using the Edwards SAPIEN 3 transcatheter heart valve (THV).	30 Days
Secondary	Number of Participants With Major Vascular Complications	The rate of major vascular complications at 30 days post implantation	30 Days
Secondary	Number of Participants With Aortic Insufficiency at 30 Days	The proportion of patients with aortic insufficiency = moderate at 30 days.	30 Days