PARTNER II Trial: S3iCAP

NCT ID: NCT02687035

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1822 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-12-31

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.

Conditions

Aortic Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAVR

Intermediate risk patients receiving transcatheter aortic valve replacement (TAVR)

Group Type: EXPERIMENTAL

SAPIEN S3 valve

Intervention Type: DEVICE

Transcatheter aortic valve replacement

Interventions

SAPIEN S3 valve

Transcatheter aortic valve replacement

Intervention Type: DEVICE

Other Intervention Names

TAVR; TAVI; Transcatheter aortic valve replacement; SAPIEN

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)

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susheel Kodali, MD

Role: PRINCIPAL_INVESTIGATOR

University of Columbia

Vinod Thourani, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Scripps Green Hospital

La Jolla, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Stanford Hospital and Clinics

Palo Alto, California, United States

Mercy General Hospital

Sacramento, California, United States

University of Colorado Hospital

Denver, Colorado, United States

Washington Hospital Center DC

Washington D.C., District of Columbia, United States

Morton Plant Hospital

Clearwater, Florida, United States

University of Florida

Gainesville, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

NorthShore University HealthSystem Research Institute

Evanston, Illinois, United States

Prairie Education and Research Cooperative

Springfield, Illinois, United States

Indiana University Health-Methodist Hospital

Indianapolis, Indiana, 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 Louisville Jewish Hospital

Louisville, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

MedStar Union Memorial Hospital

Baltimore, Maryland, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan Hospital and Health Systems

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Mayo Clinic-Saint Marys Hospital

Rochester, Minnesota, United States

Saint Luke's Hospital of Kansas City Mid America

Kansas City, Missouri, United States

Washington University/ Barnes-Jewish Hospital

St Louis, Missouri, United States

Nebraska Heart Institute

Lincoln, Nebraska, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Winthrop-University Hospital

Mineola, New York, 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

The Christ Hospital

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, United States

Providence Heart & Vascular Institute

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

York Hospital

York, Pennsylvania, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

Austin Heart, PLLC

Austin, Texas, United States

Medical City Dallas Hospital

Dallas, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, 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 Virginia

Charlottesville, Virginia, United States

Sentara Cardiovascular Research Institute

Norfolk, Virginia, United States

University of Washington

Seattle, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

St. Paul's Hospital, Providence Health Care

Vancouver, British Columbia, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 34387097 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2010-12 S3iCAP

Identifier Type: -

Identifier Source: org_study_id