REduction or eLimination of mItral rEgurgitation in degenerative or Functional mitral regurgitation with the CardiAQ-Edwards* Transcatheter Mitral Valve

Withdrawn

• Conditions: leaky heart valve; mitral regurgitation; 10046973

• Registration Number: NL-OMON43333
• Lead Sponsor: Edwards Lifesciences LLC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

General
1. * 18 years old.
2. Willing and able to comply with all required follow-up evaluations and assessments.
3. Patient or authorized representative has read the informed consent, agrees to comply with the requirements, and has signed the informed consent to participate in the study.
Heart Failure Status
4. New York Heart Associate Classification * II
5. Left Ventricular Ejection Fraction * 30%.
6. Mitral regurgitation (MR) * Grade 3+ (moderate/severe, or severe per Appendix D).
7. Patient is determined to be prohibitively high surgical risk per MVARC definition as assessed by the site*s Heart Team (a minimum of one Cardiac Surgeon and one Interventional Cardiologist).
Anatomical
8. Left atrial height * 4 cm.
9. Mitral valve major annulus diameter meets the range of 35-45 mm via CT.
10. Angle of mitral valve axis to aortic valve axis is deemed unlikely to be obstructive by the Investigator.
11. Suitable left ventricular anatomy for delivery system access per the medical opinion of the Investigator (Transapical Only).
23. Absence of CRT with Class I indication criteria for biventricular pacing
24. Hypotension (systolic pressure <90mmHg) or requirement for inotropic support or mechanical hemodynamic support.
25. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or nonischemic etiology.
26. Untreatable hypersensitivity or contraindication to any of the following:
* Aspirin and Clopidogrel and Ticlopidine,
* Heparin and Bivalirudin,
* Warfarin, Nitinol alloys (nickel and titanium), contrast media, glutaraldehyde or bovine tissue.
27. Bleeding diathesis or coagulopathy, or patient refuses blood transfusion.
28. Active peptic ulcer or GI bleeding.
29. Fixed pulmonary artery systolic pressure >70 mmHg.
30. Severe right ventricular systolic dysfunction.
31. Severe tricuspid valve regurgitation requiring intervention.
32. Pulmonary function FEV1 (< 750 cc).
33. Patients with renal insufficiency (creatinine > 2.2 mg/dL) on lab test * 48 hours prior to scheduled implant procedure and not already receiving dialysis.
34. Liver disease, cirrhosis of the liver (CTP B or C) or significantly abnormal liver function test results.
35. Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months.
36. Active infection that requires antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics). Patients must be free from infection prior to treatment. Any required dental work should be completed a minimum of 3 weeks prior to treatment.
37. Pregnant or planning pregnancy within 12 months after enrollment.

Exclusion Criteria

General
1. Currently participating in another investigational drug or device study.
2. Need for emergent or urgent surgery for any reason.
3. Any condition that, in the opinion of the Investigator, could interfere with patient participation, confound the study results or interfere with study compliance.
Anatomical
4. Lack of chordal support of the mitral valve (i.e., ruptured papillary muscle or secondary chords).
5. Severe calcification of any component of the mitral valve, including one or both of the mitral leaflets.
6. Myocardial infarction within the previous 6 weeks.
7. Intra-cardiac thrombus, mass or vegetation.
8. Aneurysmal dilatation of the left ventricular apex (Transapical Only).
9. Need for native aortic, tricuspid or pulmonic valve repair or replacement.
10. History of atrial septal repair (Transseptal Only).
11. Implanted inferior vena cava (IVC) filter (Transseptal Only).
Existing Co-morbidities
12. Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve.
13. Pre-existing mechanical prosthetic valve in the aortic position.
14. Pre-existing device in the LV apex (Transapical Only).
15. History of cardiac transplantation.
16. Any history of ilio-femoral deep vein thrombosis (Transseptal Only).
17. Clinically significant, untreated coronary artery disease.
18. Percutaneous coronary intervention, TAVR, carotid surgery, CRT, CRT-D, ICD or pacemaker within the prior 30 days.
19. Contraindication to Transesophageal Echocardiography (TEE).
20. Active endocarditis or rheumatic heart disease within the previous 3 months.
21. Stroke or TIA within the previous 3 months.
22. Uncontrolled atrial fibrillation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Freedom from MACCE (defined as all-cause mortality, myocardial infarction,<br /><br>stroke, renal failure, and conversion to surgery per MVARC definitions) at 30<br /><br>days.</p><br>