PARTNER II Trial: S3iCAP

Not Applicable

Completed

Conditions: Aortic Stenosis

Interventions: Device: SAPIEN S3 valve

Registration Number: NCT02687035

Lead Sponsor: Edwards Lifesciences

Brief Summary: Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.

Detailed Description: This multi-center, single arm registry will provide continued access of the Edwards SAPIEN 3 Transcatheter Heart Valve and delivery systems to severe aortic stenosis patients at intermediate risk for standard aortic valve replacement. Patient data will be entered into the TVT Registry (TVTR) from screening through 1 year including the collection of 5 year follow-up through CMS.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1822

Inclusion Criteria

Patients must be covered by Medicare. This will enable Edwards to link to the CMS database for long term follow-up through 5 years. No other insurance provider will be accepted.
Assessment of intermediate surgical risk defined as STS 4-8% or heart team assessment of intermediate risk factors.
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.
Aortic valve annulus area range (273mm2-680 mm2) per 3D imaging (echo, CT, or MRI).
Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
Heart team agrees (a priori) on treatment strategy for concomitant coronary disease (if present).
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.
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.

Exclusion Criteria

Heart team assessment of inoperability (including examining cardiac surgeon).
Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
Mixed aortic valve disease (aortic stenosis and aortic re-regurgitation with predominant aortic regurgitation >3+).
Pre-existing mechanical or bioprosthetic valve in any position.
Complex coronary artery disease:
1. Unprotected left main coronary artery
2. Syntax score > 32 (in the absence of prior revascularization)
Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD is not considered exclusion criteria.
Any patient with a balloon valvuloplasty (BAV) < 30 days of the procedure (unless BAV is a bridge to procedure after a qualifying ECHO).
Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation.
Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), thrombocytopenia (Plt < 50,000 cell/mL).
Hypertrophic cardiomyopathy with or without obstruction (HOCM).
Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.
Need for emergency surgery for any reason.
Severe ventricular dysfunction with LVEF < 20%.
Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
Active upper GI bleeding within 3 months (90 days) prior to procedure.
A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
Native aortic annulus size < 16 mm or > 28mm as measured by echocardiogram.
Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure.
Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening.
Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal dis-ease or chronic end stage pulmonary disease.
Expectation that patient will not improve despite treatment of aortic stenosis.
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)
Iliofemoral vessel characteristics that would preclude safe placement of 14F or 16F introducer sheath such as severe obstructive calcification, severe tortuosity or min-imum average vessel size less than 5.5 mm. (Transfem-oral).
Currently participating in an investigational drug or an-other device study. Note: Trials requiring extended fol-low-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
Active bacterial endocarditis within 6 months (180 days) of procedure.
Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis.
Inability to tolerate anticoagulation/antiplatelet therapy.
For transfemoral approach only: Femoro-iliac vessels < 5.5 mm for the 23 mm and the 26 mm system and < 6.0 mm for the 29 mm system.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAVR	SAPIEN S3 valve	Intermediate risk patients receiving transcatheter aortic valve replacement (TAVR)

Primary Outcome Measures

Name	Time	Method
Death	1 year	Number of deaths
Stroke	1 year	Number of participants with stroke
Aortic Valve Reintervention	1 year	Number of participants with aortic valve reintervention

Secondary Outcome Measures

Name	Time	Method
Major Access Vascular Site Complication	30 days	Number of participants with major vascular complications
Annular Dissection	30 days	Number of participants with annular dissection
Aortic Dissection	30 days	Number of participants with aortic dissection
Unplanned Vascular Surgery or Intervention	30 days	Number of participants with unplanned vascular surgery or intervention
Retroperitoneal Bleeds	30 days	Number of participants with retroperitoneal bleed
Gastrointestinal Bleed	30 days	Number of participants with gastrointestinal bleeding
Genitourinary Bleed	30 days	Number of participants with genitourinary bleeding
Bleeding at Access Site	30 days	Number of participants with bleeding at the access site

Trial Locations

Locations (56): MedStar Union Memorial Hospital
🇺🇸
Baltimore, Maryland, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Indiana University Health-Methodist Hospital
🇺🇸
Indianapolis, Indiana, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Scripps Green Hospital
🇺🇸
La Jolla, California, United States
Stanford Hospital and Clinics
🇺🇸
Palo Alto, California, United States
Morton Plant Hospital
🇺🇸
Clearwater, Florida, United States
Washington Hospital Center DC
🇺🇸
Washington, District of Columbia, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Prairie Education and Research Cooperative
🇺🇸
Springfield, Illinois, United States
NorthShore University HealthSystem Research Institute
🇺🇸
Evanston, Illinois, United States
St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC
🇺🇸
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸
Iowa City, Iowa, United States
University of Maryland Medical Center
🇺🇸
Baltimore, Maryland, United States
Minneapolis Heart Institute Foundation
🇺🇸
Minneapolis, Minnesota, United States
Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Nebraska Heart Institute
🇺🇸
Lincoln, Nebraska, United States
Winthrop-University Hospital
🇺🇸
Mineola, New York, United States
Newark Beth Israel Medical Center
🇺🇸
Newark, New Jersey, United States
Cornell University
🇺🇸
New York, New York, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Northshore Long Island Jewish Health System
🇺🇸
New York, New York, United States
Medical University of South Carolina Charleston
🇺🇸
Charleston, North Carolina, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
York Hospital
🇺🇸
York, Pennsylvania, United States
Baptist Memorial Hospital
🇺🇸
Memphis, Tennessee, United States
Medical City Dallas Hospital
🇺🇸
Dallas, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸
Plano, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸
Houston, Texas, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
Sentara Cardiovascular Research Institute
🇺🇸
Norfolk, Virginia, United States
University of Washington
🇺🇸
Seattle, Washington, United States
The Christ Hospital
🇺🇸
Cincinnati, Ohio, United States
The University of Texas Health Science Center at San Antonio
🇺🇸
San Antonio, Texas, United States
Intermountain Medical Center
🇺🇸
Salt Lake City, Utah, United States
University of Colorado Hospital
🇺🇸
Denver, Colorado, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
Mayo Clinic-Saint Marys Hospital
🇺🇸
Rochester, Minnesota, United States
Oklahoma Cardiovascular Research Group
🇺🇸
Oklahoma City, Oklahoma, United States
Providence Heart & Vascular Institute
🇺🇸
Portland, Oregon, United States
St. Paul's Hospital, Providence Health Care
🇨🇦
Vancouver, British Columbia, Canada
Washington University/ Barnes-Jewish Hospital
🇺🇸
Saint Louis, Missouri, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Mercy General Hospital
🇺🇸
Sacramento, California, United States
University of Louisville Jewish Hospital
🇺🇸
Louisville, Kentucky, United States
Ochsner Clinic Foundation
🇺🇸
New Orleans, Louisiana, United States
Austin Heart, PLLC
🇺🇸
Austin, Texas, United States
University of Michigan Hospital and Health Systems
🇺🇸
Ann Arbor, Michigan, United States
Saint Luke's Hospital of Kansas City Mid America
🇺🇸
Kansas City, Missouri, United States
University of Florida
🇺🇸
Gainesville, Florida, United States
University of Wisconsin
🇺🇸
Madison, Wisconsin, United States