The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B

NCT02184442 | Completed Results DMC FDA Device

• 1 other identifier: 2010-12-PIIB
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 53

Brief Summary

The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.

Conditions

Severe; Symptomatic; Calcific Aortic Stenosis

Keywords

SAPIEN; TAVR; THV; Aortic Stenosis; Heart Valve Disease; Aortic Valve; Retroflex; SAPIEN XT

Outcome Measures

Primary Outcomes (1)

• Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization

  All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year

  1 Year

Secondary Outcomes (3)

• NYHA Classification - Change From Baseline

  Baseline and 1 Year

• Total Aortic Regurgitation - Change From Baseline

  1 Year

• Effective Orifice Area - Change From Baseline

  1 Year

Study Arms (2)

TAVR - SAPIEN XT

EXPERIMENTAL

TAVR (transaortic valve replacement) with SAPIEN XT

Device: TAVR Implantation with SAPIEN XT

TAVR - SAPIEN

ACTIVE COMPARATOR

TAVR (transaortic valve replacement) with SAPIEN is the control arm

Device: TAVR Implantation with SAPIEN

Interventions

TAVR Implantation with SAPIEN XT DEVICE

Inoperable operable patients requiring the transcatheter aortic heart valve replacement

TAVR - SAPIEN XT

TAVR Implantation with SAPIEN DEVICE

Inoperable operable patients requiring the transcatheter aortic heart valve replacement

TAVR - SAPIEN

Eligibility Criteria

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

You may qualify if:

• Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
• The probability of death or serious, irreversible morbidity is greater than or equal to 50%.
• The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
• The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
• The study patient agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone follow-up.

You may not qualify if:

• Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
• 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)
• Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
• It is known that the patient is currently enrolled in the PARTNER I Trial or was withdrawn from the PARTNER I Trial prior to endpoint analysis.
• Active bacterial endocarditis within 6 months (180 days) of procedure.

Sponsors & Collaborators

• Edwards Lifesciences: lead
• American College of Cardiology: collaborator

Study Sites (53)

Arkansas Heart Hospital/Clinic

Little Rock, Arkansas, 72211, United States

Location

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Scripps Memorial 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 (WHC)

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

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

University of Florida, Gainesville

Gainesville, Florida, 32610, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

Northwestern Hospital

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, 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

The University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Louisville - Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, 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

Rochester, Minnesota, 55905, United States

Location

Saint Luke's Hospital of Kansas City Mid America

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

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Newark Beth Israel

Newark, New Jersey, 07112, United States

Location

North Shore University Hospital, NY

Manhasset, New York, 11030, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, 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

Medical University of South Carolina Charleston

Charleston, North Carolina, 29425, United States

Location

East Carolina Heart Institute at East Carolina University

Greenville, North Carolina, 27834, United States

Location

The Christ Hospital, Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73135, United States

Location

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, 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 Hospital

Dallas, Texas, 75230, United States

Location

The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center

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 (5)

• Shahim B, Redfors B, Lindman BR, Chen S, Dahlen T, Nazif T, Kapadia S, Gertz ZM, Crowley AC, Li D, Thourani VH, Kodali SK, Zajarias A, Babaliaros VC, Guyton RA, Elmariah S, Herrmann HC, Cohen DJ, Mack MJ, Smith CR, Leon MB, George I. Neutrophil-to-Lymphocyte Ratios in Patients Undergoing Aortic Valve Replacement: The PARTNER Trials and Registries. J Am Heart Assoc. 2022 Jun 7;11(11):e024091. doi: 10.1161/JAHA.121.024091. Epub 2022 Jun 3.

  PMID: 35656983 DERIVED

• Genereux P, Pibarot P, Redfors B, Bax JJ, Zhao Y, Makkar RR, Kapadia S, Thourani VH, Mack MJ, Nazif TM, Lindman BR, Babaliaros V, Vincent F, Russo M, McCabe JM, Gillam LD, Alu MC, Hahn RT, Webb JG, Leon MB, Cohen DJ. Evolution and Prognostic Impact of Cardiac Damage After Aortic Valve Replacement. J Am Coll Cardiol. 2022 Aug 23;80(8):783-800. doi: 10.1016/j.jacc.2022.05.006. Epub 2022 May 17.

  PMID: 35595203 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

MeSH Terms

Conditions

Lymphoma, Follicular; Aortic Valve, Calcification of; Aortic Valve Stenosis; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Tenley Koepnick
• Organization: Edwards Life Sciences

Tenley_Koepnick@Edwards.com

949-250-6504

Study Officials

• Martin B Leon, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: July 9, 2014
• Study Start: March 9, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 30, 2017
• Last Updated: September 25, 2018
• Results First Posted: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (53)