Clinical trial NCT03225001: PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
Official title: Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Patients With a Failing Aortic Bioprosthetic Valve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Cardiomyopathy, Hypertrophic
Keywords: SAPIEN XT
Partner II
cardiovascular disease
heart disease
aortic disease
SAVR
TAVR
failing surgical valve
failing valve
failing bioprosthetic valve
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2017-07-21
Enrollment: 197
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)
timeFrame: 30-day
Secondary outcomes:
measure: Number of Participants With Mortality From Any Cause
timeFrame: 30 Days
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center (WHC)
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Hospital
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem Research Institute
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
city: Louisville
country: United States
facility: University of Louisville Jewish Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic-Saint Marys Hospital
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City Mid America
state: Missouri
city: Saint Louis
country: United States
facility: Washington University - Barnes Jewish Hospital
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Mineola
country: United States
facility: Winthrop-University Hospital
state: New York
city: New York
country: United States
facility: Cornell University
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/ New York Presbyterian Hospital
state: New York
city: Greenville
country: United States
facility: East Carolina Heart Institute at East Carolina University
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Portland
country: United States
facility: Providence St.Vincent Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
city: Vancouver
country: Canada
facility: St. Paul's Hospital, Providence Health Care
state: British Columbia
Study officials:
affiliation: St. Paul's Hospital, Vancouver, British columbia, Canada
name: John Webb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor Heart Hospital, Plano, TX
name: Michael Mack, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shahim B, Redfors B, Lindman BR, Chen S, Dahlen T, Nazif T, Kapadia S, Gertz ZM, Crowley AC, Li D, Thourani VH, Kodali SK, Zajarias A, Babaliaros VC, Guyton RA, Elmariah S, Herrmann HC, Cohen DJ, Mack MJ, Smith CR, Leon MB, George I. Neutrophil-to-Lymphocyte Ratios in Patients Undergoing Aortic Valve Replacement: The PARTNER Trials and Registries. J Am Heart Assoc. 2022 Jun 7;11(11):e024091. doi: 10.1161/JAHA.121.024091. Epub 2022 Jun 3.
citation: Webb JG, Murdoch DJ, Alu MC, Cheung A, Crowley A, Dvir D, Herrmann HC, Kodali SK, Leipsic J, Miller DC, Pibarot P, Suri RM, Wood D, Leon MB, Mack MJ. 3-Year Outcomes After Valve-in-Valve Transcatheter Aortic Valve Replacement for Degenerated Bioprostheses: The PARTNER 2 Registry. J Am Coll Cardiol. 2019 Jun 4;73(21):2647-2655. doi: 10.1016/j.jacc.2019.03.483.