Clinical trial NCT02687035: PARTNER II Trial: S3iCAP
Official title: The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves: Continued Access Program for SAPIEN 3 Intermediate Risk (S3iCAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Keywords: S3iCAP
SAPIEN 3
Transfemoral
Commander
Certitude
TAVR
TAVI
Aortic stenosis
THV
Transcatheter Heart Valve
TVT
TVTR
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2016-02-22
Enrollment: 1822
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Death
timeFrame: 30 days
measure: Death
timeFrame: 1 year
measure: Stroke
timeFrame: 30 days
measure: Stroke
timeFrame: 1 year
measure: Aortic Valve Reintervention
timeFrame: 30 days
measure: Aortic Valve Reintervention
timeFrame: 1 year
Secondary outcomes:
measure: Annular Dissection
timeFrame: 30 days
measure: Aortic Dissection
timeFrame: 30 days
measure: Major Access Vascular Site Complication
timeFrame: 30 days
measure: Unplanned Vascular Surgery or Intervention
timeFrame: 30 days
measure: Retroperitoneal Bleeds
timeFrame: 30 days
measure: Gastrointestinal Bleed
timeFrame: 30 days
measure: Genitourinary Bleed
timeFrame: 30 days
measure: Bleeding at Access Site
timeFrame: 30 days
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center DC
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
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: Indianapolis
country: United States
facility: Indiana University Health-Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
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: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
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 Hospital and Health Systems
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
state: New York
city: New York
country: United States
facility: Northshore Long Island Jewish Health System
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina Charleston
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
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 Cardiovascular Research Group
state: Oklahoma
city: Portland
country: United States
facility: Providence Heart & Vascular Institute
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Austin
country: United States
facility: Austin Heart, PLLC
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
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
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 Cardiovascular Research Institute
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Vancouver
country: Canada
facility: St. Paul's Hospital, Providence Health Care
state: British Columbia
Study officials:
affiliation: University of Columbia
name: Susheel Kodali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Vinod Thourani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.