ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral

Mitral Regurgitation Clinical Trial

Official title:

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve - Mitral

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06167213
• Other study ID #: 2021-05-Mitral
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: March 2038

Study information

• Verified date: December 2023
• 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

This study will establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring.

Description:

This is a prospective, single arm, multicenter, pivotal study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: March 2038
• Est. primary completion date: March 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring demonstrating = moderate stenosis and/or = moderate insufficiency

2. Bioprosthetic surgical valve or native mitral annulus 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. Interatrial septum or left atrium not suitable for transcatheter transseptal access

3. Failing valve has mild or greater paravalvular regurgitation

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

5. Annuloplasty ring dehiscence

6. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient > 10 mmHg at the end of the index procedure for implantation of the original valve

7. Annuloplasty ring type not favorable for THV implantation

8. Increased risk of THV embolization

9. Anatomical characteristics that would increase risk of left ventricular outflow tract (LVOT) obstruction

10. Surgical or transcatheter aortic valve extending into LVOT that may impinge on the mitral implant

11. Severe right ventricle (RV) dysfunction

12. Severe regurgitation or stenosis of any other valve

13. Need for aortic, tricuspid, or pulmonic valve intervention within the next 12 months

14. Left ventricular ejection fraction < 20%

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

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

17. Hypertrophic cardiomyopathy with subvalvular obstruction

18. Subjects with planned concomitant ablation for atrial fibrillation

19. Clinically significant coronary artery disease requiring revascularization

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

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

22. Endocarditis within 180 days prior to the study procedure

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

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

25. Renal insufficiency and/or renal replacement therapy

26. Leukopenia, anemia, thrombocytopenia

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

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

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

30. Subject refuses blood products

31. Body mass index > 50 kg/m2

32. Estimated life expectancy < 24 months

33. Female who is pregnant or lactating

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

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

36. Subject considered to be part of a vulnerable population

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Stenosis
• Mitral Valve Disease
• Mitral Valve Insufficiency
• Mitral Valve Stenosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-hierarchical composite of death and stroke at 1 year	The number of patients that died or had a stroke	1 year
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline	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	Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline	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.	1 year
Secondary	New York Heart Association (NYHA) functional class compared to baseline	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	New York Heart Association (NYHA) functional class compared to baseline	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.	1 year