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)

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.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: SAPIEN S3 valve

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.

• Study Type: Interventional
• Enrollment (Actual): 1822
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital, Providence Health Care
• United States
  • California
    • La Jolla, California, United States, 92307
      • Scripps Green Hospital
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Palo Alto, California, United States, 94305
      • Stanford Hospital and Clinics
    • Sacramento, California, United States, 95816
      • Mercy General Hospital
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center DC
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Gainesville, Florida, United States, 32615
      • University of Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Evanston, Illinois, United States, 60201
      • Northshore University Healthsystem Research Institute
    • Springfield, Illinois, United States, 62701
      • Prairie Education And Research Cooperative
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health-Methodist Hospital
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Jewish Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
    • Baltimore, Maryland, United States, 21201
      • MedStar Union Memorial Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital and Health Systems
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic-Saint Marys Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City Mid America
    • Saint Louis, Missouri, United States, 63110
      • Washington University/ Barnes-Jewish Hospital
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Nebraska Heart Institute
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Newark, New Jersey, United States, 07112
      • Newark Beth Israel Medical Center
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop-University Hospital
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10021
      • Cornell University
    • New York, New York, United States, 10075
      • Northshore Long Island Jewish Health System
  • North Carolina
    • Charleston, North Carolina, United States, 29425
      • Medical University of South Carolina Charleston
    • Durham, North Carolina, United States, 27712
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Cardiovascular Research Group
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Heart & Vascular Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • York, Pennsylvania, United States, 17403
      • York Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart, PLLC
    • Dallas, Texas, United States, 75230
      • Medical City Dallas Hospital
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center at San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84157
      • Intermountain Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • University of Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Cardiovascular Research Institute
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Assessment of intermediate surgical risk defined as STS 4-8% or heart team assessment of intermediate risk factors.
3. 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.
4. Aortic valve annulus area range (273mm2-680 mm2) per 3D imaging (echo, CT, or MRI).
5. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
6. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
7. Heart team agrees (a priori) on treatment strategy for concomitant coronary disease (if present).
8. 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.
9. 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:

1. Heart team assessment of inoperability (including examining cardiac surgeon).
2. 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)].
3. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
4. Mixed aortic valve disease (aortic stenosis and aortic re-regurgitation with predominant aortic regurgitation >3+).
5. Pre-existing mechanical or bioprosthetic valve in any position.

6. Complex coronary artery disease:

   1. Unprotected left main coronary artery
   2. Syntax score > 32 (in the absence of prior revascularization)
7. 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.
8. Any patient with a balloon valvuloplasty (BAV) < 30 days of the procedure (unless BAV is a bridge to procedure after a qualifying ECHO).
9. Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation.
10. Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), thrombocytopenia (Plt < 50,000 cell/mL).
11. Hypertrophic cardiomyopathy with or without obstruction (HOCM).
12. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.
13. Need for emergency surgery for any reason.
14. Severe ventricular dysfunction with LVEF < 20%.
15. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
16. Active upper GI bleeding within 3 months (90 days) prior to procedure.
17. A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
18. Native aortic annulus size < 16 mm or > 28mm as measured by echocardiogram.
19. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure.
20. Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening.
21. Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal dis-ease or chronic end stage pulmonary disease.
22. Expectation that patient will not improve despite treatment of aortic stenosis.
23. 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)
24. 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).
25. 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.
26. Active bacterial endocarditis within 6 months (180 days) of procedure.
27. Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis.
28. Inability to tolerate anticoagulation/antiplatelet therapy.
29. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAVR; Intermediate risk patients receiving transcatheter aortic valve replacement (TAVR)	Device: SAPIEN S3 valve; Transcatheter aortic valve replacement; Other Names: TAVI; TAVR; Transcatheter aortic valve replacement; SAPIEN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Susheel Kodali, MD, University of Columbia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimate): February 22, 2016

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: March 12, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: TAVI; Aortic stenosis; Transfemoral; TVT; TAVR; SAPIEN 3; THV; Transcatheter Heart Valve; S3iCAP; Commander; Certitude; TVTR
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2010-12 S3iCAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes