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

Aortic Valve Stenosis Clinical Trial

Official title:

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05172973
• Other study ID #: 2021-05-AVIV
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2023
• Est. completion date: February 2034

Study information

• Verified date: May 2024
• Source: Edwards Lifesciences
• Contact: Edwards THV Clinical Affairs
• Phone: 949-250-2500
• Email: THV_CT.gov[@]Edwards.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Prospective, single arm, multicenter study

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2034
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Failing aortic bioprosthetic valve demonstrating = moderate stenosis and/or = moderate insufficiency

2. Bioprosthetic valve size suitable for SAPIEN X4 THV

3. NYHA functional class = II

4. Heart Team agrees the subject is at high or greater surgical risk

5. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system

2. Failing valve has moderate or severe paravalvular regurgitation

3. Failing valve is unstable, rocking, or not structurally intact

4. 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

5. Increased risk of THV embolization

6. Surgical or transcatheter valve in the mitral position

7. Severe mitral regurgitation (> 3+) or = moderate mitral stenosis

8. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months

9. Left ventricular ejection fraction < 20%

10. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation

11. Increased risk of coronary artery obstruction after THV implantation

12. Myocardial infarction within 30 days prior to the study procedure

13. Hypertrophic cardiomyopathy with subvalvular obstruction

14. Subjects with planned concomitant ablation for atrial fibrillation

15. Clinically significant coronary artery disease requiring revascularization

16. Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.

17. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure

18. Endocarditis within 180 days prior to the study procedure

19. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure

20. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure

21. Renal insufficiency and/or renal replacement therapy

22. Leukopenia, anemia, thrombocytopenia

23. Inability to tolerate or condition precluding treatment with antithrombotic therapy

24. Hypercoagulable state or other condition that increases risk of thrombosis

25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication

26. Subject refuses blood products

27. Body mass index > 50 kg/m2

28. Estimated life expectancy < 24 months

29. Female who is pregnant or lactating

30. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments

31. Participating in another investigational drug or device study that has not reached its primary endpoint

32. Subject considered to be part of a vulnerable population

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Stenosis

Intervention

Device:
• SAPIEN X4 THV
Implantation of the SAPIEN X4 valve

Locations

Country	Name	City	State
Canada	St. Paul's Hospital Vancouver	Vancouver	British Columbia
United States	Emory University Atlanta	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	MedStar Union Memorial Hospital	Baltimore	Maryland
United States	Carolinas Health System	Charlotte	North Carolina
United States	Novant Health and Vascular Institute	Charlotte	North Carolina
United States	The Christ Hospital	Cincinnati	Ohio
United States	University of Texas Memorial Hermann	Houston	Texas
United States	UC Health Medical Center of the Rockies	Loveland	Colorado
United States	Atlantic Health System Morristown	Morristown	New Jersey
United States	Naples Community Hospital Healthcare System	Naples	Florida
United States	Saint Thomas Health	Nashville	Tennessee
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Columbia University Medical Center / NYPH	New York	New York
United States	Cornelll University New York	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Stanford University Medical Center	Stanford	California
United States	Oklahoma Heart Institute	Tulsa	Oklahoma
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-hierarchical composite of death and stroke	The number of patients that died or had a stroke	1 year
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ) score	The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.	30 days
Secondary	KCCQ score		1 year
Secondary	New York Heart Association (NYHA) functional class	NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.	30 days
Secondary	NYHA functional class		1 year