PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate

NCT03222128 | Completed Results DMC FDA Device

• 1 other identifier: 2010-12 PIIS3i
• Study Type: interventional
• Target: 1,074
• Locations: 1 country
• Sites: 51

Brief Summary

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.

Conditions

Symptomatic Severe Aortic Stenosis

Keywords

SAPIEN 3; Transfemoral; Transapical; Transaortic; NovaFlex; TAVI; Aortic Stenosis; THV; Aortic Valve; Transcatheter Heart Valve; TAVR

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate

  1 year

Secondary Outcomes (1)

• Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days

  30 Days

Study Arms (1)

PIIS3i - SAPIEN 3

EXPERIMENTAL

PIIS3i - SAPIEN 3 is Operable Group

Device: TAVR

Interventions

TAVR DEVICE

Implantation of the SAPIEN 3

PIIS3i - SAPIEN 3

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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).
• Complex coronary artery disease
• Unprotected left main coronary artery
• Syntax score \> 32 (in the absence of prior revascularization)
• 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.

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (51)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Mercy General Hospital

Sacramento, California, 95816, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of Colorado Hospital

Denver, Colorado, 80045, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

University of Florida

Gainesville, Florida, 32615, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Northshore

Evanston, Illinois, 60201, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States

Location

Indiana University Health-Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

St. Vincent Medical Group, Inc./St. Vincent Heart Center of Indiana, LLC

Indianapolis, Indiana, 46290, United States

Location

The University of Iowa

Iowa City, Iowa, 52242, United States

Location

The Jewish Hospital Medical Center

Louisville, Kentucky, 40202, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic-Saint Marys Hospital

Rochester, Minnesota, 55905, United States

Location

St. Luke's Hospital - Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

Washington University - Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Northshore Long Island Jewish Health System

New Hyde Park, New York, 11040, United States

Location

Cornell University

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke University

Durham, North Carolina, 27712, United States

Location

East Carolina Heart Institute at East Carolina University

Greenville, North Carolina, 27834, United States

Location

The Lindner Center for Research & Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

Location

Providence Heart & Vascular Institute at Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Austin Heart, PLLC

Austin, Texas, 78756, United States

Location

The Heart Hospital Baylor Plano

Dallas, Texas, 75093, United States

Location

Medical City Dallas

Dallas, Texas, 75230, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio (UTHSCSA)

San Antonio, Texas, 78229-3900, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (10)

• Madhavan MV, Kodali SK, Thourani VH, Makkar R, Mack MJ, Kapadia S, Webb JG, Cohen DJ, Herrmann HC, Williams M, Greason K, Pibarot P, Hahn RT, Jaber W, Xu K, Alu M, Smith CR, Leon MB. Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement Compared With Surgical Valve Replacement in Intermediate-Risk Patients. J Am Coll Cardiol. 2023 Jul 11;82(2):109-123. doi: 10.1016/j.jacc.2023.04.049.

  PMID: 37407110 DERIVED

• Vincent F, Thourani VH, Ternacle J, Redfors B, Cohen DJ, Hahn RT, Li D, Crowley A, Webb JG, Mack MJ, Kapadia S, Russo M, Smith CR, Alu MC, Leon MB, Pibarot P. Time-of-Day and Clinical Outcomes After Surgical or Transcatheter Aortic Valve Replacement: Insights From the PARTNER Trials. Circ Cardiovasc Qual Outcomes. 2022 Jan;15(1):e007948. doi: 10.1161/CIRCOUTCOMES.121.007948. Epub 2022 Jan 18.

  PMID: 35041482 DERIVED

• Herrmann HC, Cohen DJ, Hahn RT, Babaliaros VC, Yu X, Makkar R, McCabe J, Szerlip M, Kapadia S, Russo M, Malaisrie SC, Webb JG, Szeto WY, Kodali S, Thourani VH, Mack MJ, Leon MB. Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2021 Jul;14(7):e010310. doi: 10.1161/CIRCINTERVENTIONS.120.010310. Epub 2021 Jun 16.

  PMID: 34130476 DERIVED

• Brener MI, George I, Kosmidou I, Nazif T, Zhang Z, Dizon JM, Garan H, Malaisrie SC, Makkar R, Mack M, Szeto WY, Fearon WF, Thourani VH, Leon MB, Kodali S, Biviano AB. Atrial Fibrillation Is Associated With Mortality in Intermediate Surgical Risk Patients With Severe Aortic Stenosis: Analyses From the PARTNER 2A and PARTNER S3i Trials. J Am Heart Assoc. 2021 Apr 6;10(7):e019584. doi: 10.1161/JAHA.120.019584. Epub 2021 Mar 23.

  PMID: 33754803 DERIVED

• Ong G, Pibarot P, Redfors B, Weissman NJ, Jaber WA, Makkar RR, Lerakis S, Gopal D, Khalique O, Kodali SK, Thourani VH, Anwaruddin S, McAndrew T, Zhang Y, Alu MC, Douglas PS, Hahn RT. Diastolic Function and Clinical Outcomes After Transcatheter Aortic Valve Replacement: PARTNER 2 SAPIEN 3 Registry. J Am Coll Cardiol. 2020 Dec 22;76(25):2940-2951. doi: 10.1016/j.jacc.2020.10.032.

  PMID: 33334422 DERIVED

• Pibarot P, Ternacle J, Jaber WA, Salaun E, Dahou A, Asch FM, Weissman NJ, Rodriguez L, Xu K, Annabi MS, Guzzetti E, Beaudoin J, Bernier M, Leipsic J, Blanke P, Clavel MA, Rogers E, Alu MC, Douglas PS, Makkar R, Miller DC, Kapadia SR, Mack MJ, Webb JG, Kodali SK, Smith CR, Herrmann HC, Thourani VH, Leon MB, Hahn RT; PARTNER 2 Investigators. Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial. J Am Coll Cardiol. 2020 Oct 20;76(16):1830-1843. doi: 10.1016/j.jacc.2020.08.049.

  PMID: 33059828 DERIVED

• Chen S, Redfors B, O'Neill BP, Clavel MA, Pibarot P, Elmariah S, Nazif T, Crowley A, Ben-Yehuda O, Finn MT, Alu MC, Vahl TP, Kodali S, Leon MB, Lindman BR. Low and elevated B-type natriuretic peptide levels are associated with increased mortality in patients with preserved ejection fraction undergoing transcatheter aortic valve replacement: an analysis of the PARTNER II trial and registry. Eur Heart J. 2020 Feb 21;41(8):958-969. doi: 10.1093/eurheartj/ehz892.

  PMID: 31883339 DERIVED

• Summers MR, Leon MB, Smith CR, Kodali SK, Thourani VH, Herrmann HC, Makkar RR, Pibarot P, Webb JG, Leipsic J, Alu MC, Crowley A, Hahn RT, Kapadia SR, Tuzcu EM, Svensson L, Cremer PC, Jaber WA. Prosthetic Valve Endocarditis After TAVR and SAVR: Insights From the PARTNER Trials. Circulation. 2019 Dec 10;140(24):1984-1994. doi: 10.1161/CIRCULATIONAHA.119.041399. Epub 2019 Nov 6.

  PMID: 31690104 DERIVED

• Furer A, Chen S, Redfors B, Elmariah S, Pibarot P, Herrmann HC, Hahn RT, Kodali S, Thourani VH, Douglas PS, Alu MC, Fearon WF, Passeri J, Malaisrie SC, Crowley A, McAndrew T, Genereux P, Ben-Yehuda O, Leon MB, Burkhoff D. Effect of Baseline Left Ventricular Ejection Fraction on 2-Year Outcomes After Transcatheter Aortic Valve Replacement: Analysis of the PARTNER 2 Trials. Circ Heart Fail. 2019 Aug;12(8):e005809. doi: 10.1161/CIRCHEARTFAILURE.118.005809. Epub 2019 Aug 1.

  PMID: 31525069 DERIVED

• Nazif TM, Chen S, George I, Dizon JM, Hahn RT, Crowley A, Alu MC, Babaliaros V, Thourani VH, Herrmann HC, Smalling RW, Brown DL, Mack MJ, Kapadia S, Makkar R, Webb JG, Leon MB, Kodali SK. New-onset left bundle branch block after transcatheter aortic valve replacement is associated with adverse long-term clinical outcomes in intermediate-risk patients: an analysis from the PARTNER II trial. Eur Heart J. 2019 Jul 14;40(27):2218-2227. doi: 10.1093/eurheartj/ehz227.

  PMID: 31505615 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Director of Research
• Organization: Edwards Lifesciences

THV_CT.gov@Edwards.com

949-250-2500

Study Officials

• Martin B Leon, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Craig Smith, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: July 17, 2017
• First Posted: July 19, 2017
• Study Start: February 17, 2014
• Primary Completion: November 18, 2015
• Study Completion: October 9, 2024
• Last Updated: January 3, 2025
• Results First Posted: August 14, 2018

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (51)