ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

NCT05172973 | Recruiting DMC FDA Device

• 1 other identifier: 2021-05-AVIV
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 35

Brief Summary

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

Conditions

Aortic Valve Insufficiency; Aortic Valve Stenosis

Keywords

Transcatheter aortic valve replacement (TAVR); Transcatheter aortic valve implantation (TAVI); SAPIEN X4; Valve-in-valve

Outcome Measures

Primary Outcomes (1)

• Non-hierarchical composite of death and stroke

  The number of patients that died or had a stroke

  1 year

Secondary Outcomes (4)

• Kansas City Cardiomyopathy Questionnaire (KCCQ) score

  30 days

• KCCQ score

  1 year

• New York Heart Association (NYHA) functional class

  30 days

• NYHA functional class

  1 year

Study Arms (2)

Transcatheter Aortic Valve Replacement (TAVR) - Surgical Valve

EXPERIMENTAL

TAVR implant in subjects with a failing aortic surgical valve.

Device: SAPIEN X4 THV

Transcatheter Aortic Valve Replacement (TAVR) - THV

EXPERIMENTAL

TAVR implant in subjects with a failing aortic transcatheter heart valve (THV).

Device: SAPIEN X4 THV

Interventions

SAPIEN X4 THV DEVICE

Implantation of the SAPIEN X4 valve

Transcatheter Aortic Valve Replacement (TAVR) - Surgical Valve; Transcatheter Aortic Valve Replacement (TAVR) - THV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
• Bioprosthetic valve size suitable for SAPIEN X4 THV
• NYHA functional class ≥ II
• Heart Team agrees the subject is at high or greater surgical risk
• The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

You may not qualify if:

• Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
• Failing valve has moderate or severe paravalvular regurgitation
• Failing valve is unstable, rocking, or not structurally intact
• Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \> 20 mmHg at the end of the index procedure for implantation of the original valve
• Increased risk of THV embolization
• Surgical or transcatheter valve in the mitral position
• Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis
• Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
• Left ventricular ejection fraction \< 20%
• Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
• Increased risk of coronary artery obstruction after THV implantation
• Myocardial infarction within 30 days prior to the study procedure
• Hypertrophic cardiomyopathy with subvalvular obstruction
• Subjects with planned concomitant ablation for atrial fibrillation
• Clinically significant coronary artery disease requiring revascularization

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (35)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

RECRUITING

Bay Area Structural Heart at Sutter Health

San Francisco, California, 94105, United States

RECRUITING

Kaiser San Francisco

San Francisco, California, 94115, United States

RECRUITING

Stanford University Medical Center

Stanford, California, 94305, United States

RECRUITING

UC Health Medical Center of the Rockies

Loveland, Colorado, 80538, United States

RECRUITING

Naples Community Hospital Healthcare System

Naples, Florida, 34102, United States

RECRUITING

Emory University Atlanta

Atlanta, Georgia, 30308, United States

RECRUITING

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

RECRUITING

Northwestern University Chicago

Evanston, Illinois, 60208, United States

RECRUITING

Alexian Brothers Hospital Network

Lisle, Illinois, 60532, United States

RECRUITING

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States

RECRUITING

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Henry Ford Hospital Detroit

Detroit, Michigan, 48202, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Atlantic Health System Morristown

Morristown, New Jersey, 07960, United States

RECRUITING

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

RECRUITING

University of Buffalo

Buffalo, New York, 14203, United States

RECRUITING

Cornelll University New York

New York, New York, 10021, United States

RECRUITING

Columbia University Medical Center / NYPH

New York, New York, 10032, United States

RECRUITING

Rochester General Hospital

Rochester, New York, 14621, United States

RECRUITING

Carolinas Health System

Charlotte, North Carolina, 28204, United States

RECRUITING

Novant Health and Vascular Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Saint Thomas Health

Nashville, Tennessee, 37205, United States

RECRUITING

University of Texas Memorial Hermann

Houston, Texas, 77030, United States

RECRUITING

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

RECRUITING

University of Washington Seattle

Seattle, Washington, 98195, United States

WITHDRAWN

St. Paul's Hospital Vancouver

Vancouver, British Columbia, V6Z1Y6, Canada

RECRUITING

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval

Québec, G1V4G5, Canada

RECRUITING

MeSH Terms

Conditions

Aortic Valve Insufficiency; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Pradeep Yadav, MD

  Piedmont Atlanta Hospital

  PRINCIPAL INVESTIGATOR

• Robert Cubbedu, MD

  Naples Community Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edwards THV Clinical Affairs

CONTACT

949-250-2500; THV_CT.gov@Edwards.com

Study Design

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

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: December 29, 2021
• Study Start: November 22, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2036
• Last Updated: December 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (32); CA (3)