PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve

NCT ID: NCT03225001

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-11
• Study Completion Date: 2020-10-28

Brief Summary

To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.

Detailed Description

A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency. This is a PARTNER II nested registry.

Conditions

Aortic Stenosis; Cardiomyopathy, Hypertrophic

Study Design

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

Study Groups

Failing surgical valve

Patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.

Group Type: EXPERIMENTAL

Edwards SAPIEN XT transcatheter valve, Model 9300TFX

Intervention Type: DEVICE

Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.

Interventions

Edwards SAPIEN XT transcatheter valve, Model 9300TFX

Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.

Intervention Type: DEVICE

Other Intervention Names

TAVI

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

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

4. 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.

5. Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.

6. Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic position.

Exclusion Criteria

1. Bioprosthetic valve labeled external diameter < 21mm.

2. Surgical or transcatheter valve in another position on the same side of the heart (mitral and tricuspid rings are not an exclusion).

3. Infectious endocarditis within 6 months.

4. Acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Webb, MD

Role: PRINCIPAL_INVESTIGATOR

St. Paul's Hospital, Vancouver, British columbia, Canada

Michael Mack, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Heart Hospital, Plano, TX

Locations

Scripps Green Hospital

La Jolla, California, United States

Scripps Memorial Hospital

La Jolla, California, United States

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 (WHC)

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

Morton Plant Hospital

Clearwater, Florida, United States

University of Miami

Miami, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Northwestern Hospital

Chicago, Illinois, United States

NorthShore University HealthSystem Research Institute

Evanston, Illinois, United States

Prairie Education and Research Cooperative

Springfield, Illinois, United States

The University of Iowa

Iowa City, Iowa, United States

University of Louisville Jewish Hospital

Louisville, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan

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 Presbyterian Hospital

New York, New York, United States

East Carolina Heart Institute at East Carolina University

Greenville, 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

Medical University of South Carolina

Charleston, South Carolina, United States

The Heart Hospital Baylor Plano

Dallas, Texas, United States

Medical City Dallas Hospital

Dallas, Texas, United States

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

Houston, Texas, United States

Intermountain Medical Center

Salt Lake City, 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

University of Wisconsin - Madison

Madison, Wisconsin, United States

St. Paul's Hospital, Providence Health Care

Vancouver, British Columbia, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 35656983 (View on PubMed)

Webb JG, Murdoch DJ, Alu MC, Cheung A, Crowley A, Dvir D, Herrmann HC, Kodali SK, Leipsic J, Miller DC, Pibarot P, Suri RM, Wood D, Leon MB, Mack MJ. 3-Year Outcomes After Valve-in-Valve Transcatheter Aortic Valve Replacement for Degenerated Bioprostheses: The PARTNER 2 Registry. J Am Coll Cardiol. 2019 Jun 4;73(21):2647-2655. doi: 10.1016/j.jacc.2019.03.483.

Reference Type: DERIVED

PMID: 31146808 (View on PubMed)

Other Identifiers

2010-12 NR3/ViV

Identifier Type: -

Identifier Source: org_study_id