PARTNER II Trial: S3iCAP
PII S3i CAP
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves: Continued Access Program for SAPIEN 3 Intermediate Risk (S3iCAP)
1 other identifier
interventional
1,822
2 countries
56
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedResults Posted
Study results publicly available
April 8, 2021
CompletedApril 8, 2021
December 1, 2020
2.8 years
February 1, 2016
December 22, 2020
March 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Death
Number of deaths
30 days
Death
Number of deaths
1 year
Stroke
Number of participants with stroke
30 days
Stroke
Number of participants with stroke
1 year
Aortic Valve Reintervention
Number of participants with aortic valve reintervention
30 days
Aortic Valve Reintervention
Number of participants with aortic valve reintervention
1 year
Secondary Outcomes (8)
Annular Dissection
30 days
Aortic Dissection
30 days
Major Access Vascular Site Complication
30 days
Unplanned Vascular Surgery or Intervention
30 days
Retroperitoneal Bleeds
30 days
- +3 more secondary outcomes
Study Arms (1)
TAVR
EXPERIMENTALIntermediate risk patients receiving transcatheter aortic valve replacement (TAVR)
Interventions
Transcatheter aortic valve replacement
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- Unprotected left main coronary artery
- Syntax score \> 32 (in the absence of prior revascularization)
- 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%.
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Scripps Green Hospital
La Jolla, California, 92307, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Stanford Hospital and Clinics
Palo Alto, California, 94305, United States
Mercy General Hospital
Sacramento, California, 95816, United States
University of Colorado Hospital
Denver, Colorado, 80045, United States
Washington Hospital Center DC
Washington D.C., District of Columbia, 20010, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
University of Florida
Gainesville, Florida, 32615, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
NorthShore University HealthSystem Research Institute
Evanston, Illinois, 60201, United States
Prairie Education and Research Cooperative
Springfield, Illinois, 62701, United States
Indiana University Health-Methodist Hospital
Indianapolis, Indiana, 46202, United States
St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC
Indianapolis, Indiana, 46290, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Louisville Jewish Hospital
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, 21201, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Mayo Clinic-Saint Marys Hospital
Rochester, Minnesota, 55905, United States
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri, 64111, United States
Washington University/ Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Nebraska Heart Institute
Lincoln, Nebraska, 68526, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Winthrop-University Hospital
Mineola, New York, 11501, United States
Cornell University
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
Northshore Long Island Jewish Health System
New York, New York, 10075, United States
Medical University of South Carolina Charleston
Charleston, North Carolina, 29425, United States
Duke University Medical Center
Durham, North Carolina, 27712, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120, United States
Providence Heart & Vascular Institute
Portland, Oregon, 97225, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
York Hospital
York, Pennsylvania, 17403, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
Austin Heart, PLLC
Austin, Texas, 78756, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Intermountain Medical Center
Salt Lake City, Utah, 84157, United States
University of Virginia
Charlottesville, Virginia, 22904, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507, United States
University of Washington
Seattle, Washington, 98195, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
St. Paul's Hospital, Providence Health Care
Vancouver, British Columbia, V6Z 1Y6, Canada
Related Publications (1)
Abbas AE, Ternacle J, Pibarot P, Xu K, Alu M, Rogers E, Hahn RT, Leon M, Thourani VH. Impact of Flow on Prosthesis-Patient Mismatch Following Transcatheter and Surgical Aortic Valve Replacement. Circ Cardiovasc Imaging. 2021 Aug;14(8):e012364. doi: 10.1161/CIRCIMAGING.120.012364. Epub 2021 Aug 13.
PMID: 34387097DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Edwards THV Clinical Affairs
- Organization
- Edwards Lifesciences
Study Officials
- PRINCIPAL INVESTIGATOR
Susheel Kodali, MD
University of Columbia
- PRINCIPAL INVESTIGATOR
Vinod Thourani, MD
Emory University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2016
First Posted
February 22, 2016
Study Start
January 1, 2015
Primary Completion
October 1, 2017
Study Completion
December 1, 2018
Last Updated
April 8, 2021
Results First Posted
April 8, 2021
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share