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

NCT ID: NCT03222141

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 583 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2020-08-31

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.

Detailed Description

This is a prospective, non-randomized, multi-center trial for patients undergoing aortic valve replacement with the Edwards SAPIEN 3 THV for severe aortic stenosis. Patient cohorts will include those inoperable and those considered as a high surgical risk (STS ≥8%). The study also includes NR7 patients (patients with a 20mm vessel size).

Conditions

Symptomatic Severe Aortic Stenosis

Study Design

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

Study Groups

SAPIEN 3™ valve

Group Type: EXPERIMENTAL

TAVR Implantation of the THV Prosthesis

Intervention Type: DEVICE

Patients with TAVR implantation

Interventions

TAVR Implantation of the THV Prosthesis

Patients with TAVR implantation

Intervention Type: DEVICE

Other Intervention Names

SAPIEN 3™valve

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.

3. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.

4. 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.

5. 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.

6. STS > 8

Exclusion Criteria

1. Pre-existing mechanical or bioprosthetic valve in any position.

2. Active bacterial endocarditis within 6 months (180 days) of procedure.

3. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.

5. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin B Leon, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Mercy General Hospital

Sacramento, California, United States

Stanford University Medical Center

Stanford, 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

Emory University

Atlanta, Georgia, United States

Northwestern Hospital

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Prairie Education and Research Cooperative

Springfield, Illinois, United States

Indiana University Health-Methodist Hospital

Indianapolis, Indiana, United States

The University of Iowa

Iowa City, Iowa, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

MedStar Union Memorial Hospital

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University - Barnes Jewish Hospital

St Louis, Missouri, United States

Nebraska Heart Institute

Lincoln, Nebraska, 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

Duke University

Durham, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

Providence St.Vincent Medical Center

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

York Hospital

York, Pennsylvania, United States

Austin Heart, PLLC

Austin, Texas, United States

Medical City Dallas

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

Intermountain Medical Center

Murray, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

University of Washington

Seattle, Washington, United States

St. Paul's Hospital, Providence Health Care

Vancouver, British Columbia, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 35041482 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33334422 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31883339 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31690104 (View on PubMed)

Other Identifiers

2010-12 S3HR/NR7

Identifier Type: -

Identifier Source: org_study_id