PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7

NCT03222141 | Completed Results DMC FDA Device

• 1 other identifier: 2010-12 S3HR/NR7
• Study Type: interventional
• Target: 583
• Locations: 2 countries
• Sites: 40

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, severe aortic stenosis, and are in high risk.

Conditions

Symptomatic Severe Aortic Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate

  The composite rate of all-cause mortality, all stroke, and AI ≥ moderate for patients deemed as 'high risk' using the Edwards SAPIEN 3 transcatheter heart valve (THV).

  30 Days

Secondary Outcomes (2)

• Number of Participants With Major Vascular Complications

  30 Days

• Number of Participants With Aortic Insufficiency at 30 Days

  30 Days

Study Arms (1)

SAPIEN 3™ valve

EXPERIMENTAL

Device: TAVR Implantation of the THV Prosthesis

Interventions

TAVR Implantation of the THV Prosthesis DEVICE

Patients with TAVR implantation

Also known as: SAPIEN 3™valve

SAPIEN 3™ valve

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.
• STS \> 8

You may not qualify if:

• Pre-existing mechanical or bioprosthetic valve in any position.
• Active bacterial endocarditis within 6 months (180 days) of procedure.
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (40)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Mercy General Hospital

Sacramento, California, 95819, 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 DC

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

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Emory University

Atlanta, Georgia, 30322, 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

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, 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

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

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

The Christ Hospital

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

Providence St.Vincent Medical Center

Portland, Oregon, 97225, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Austin Heart, PLLC

Austin, Texas, 78756, 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

The Heart Hospital Baylor Plano

Plano, Texas, 75093, 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

St. Paul's Hospital, Providence Health Care

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (4)

• 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

• 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

• 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

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: Edwards THV Clinical Affairs
• Organization: Edwards Lifesciences

THV_CT.gov@Edwards.com

(949) 250-2500

Study Officials

• Martin B Leon, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: October 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: August 1, 2020
• Last Updated: May 12, 2021
• Results First Posted: August 14, 2018

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (39)