leaky heart valve mitral regurgitation
Conditions
Interventions
Sponsors
CardiAQ Valve Technologies, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: General 1. * 65 years old. 2. Willing and able to comply with all required follow-up evaluations and assessments. 3. Subject 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 * III 5. Left Ventricular Ejection Fraction * 30%. 6. Mitral regurgitation (MR) * Grade 3+ (moderate/severe, or severe) using the AHA/ACC 2014 Guidelines for the Management of Patients with Valvular Heart Disease (as published in Circulation March 3, 2014). 7. STS mortality score * 8% or determined to be high or extreme surgical risk by a Cardiac Surgeon. 8. Hemodynamically stable while on heart failure medication for at least 30 days before the procedure. Anatomical 9. Left atrial height * 4 cm. 10. Left Ventricular End Systolic Diameter (LVESD) * 6 cm. 11. Mitral valve major (single axis) annulus diameter meets the range of 36-39.5 mm. 12. Angle of mitral valve axis to aortic valve axis is deemed unlikely to be obstructive by the Investigator. 13. Suitable left ventricular anatomy for delivery system access per the medical opinion of the Investigator.
Exclusion criteria
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 Subject 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. Need for native aortic or pulmonic valve replacement. Existing Co-morbidities 9. Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve. 10. Pre-existing mechanical prosthetic valve in the aortic position. 11. History of cardiac transplantation. 12. Any history of pulmonary embolism. 13. Clinically significant, untreated coronary artery disease. 14. Percutaneous coronary intervention within the prior 30 days. 15. Contraindication to Transesophageal/Transoesophageal Echocardiography (TEE/TOE). 16. Active endocarditis or rheumatic heart disease within the previous 3 months. 17. Refractory, unstable angina. 18. Significant cerebral vascular event within the previous 3 months. 19. Atrial fibrillation with uncontrolled heart rate (> 100 bpm). 20. Hemodynamic instability (systolic pressure 55 mmHg) and severe COPD (FEV1/FVC 194 µmol/L (2.2 mg/dL) OR * eGFR * 30 mL/min. 29. Liver disease, cirrhosis of the liver or significantly abnormal liver function test results. 30. Significant uncorrected endocrinology deficiency. 31. Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the percentage of Subjects with a composite Major Adverse Event (MAE) at 30 days for the following events: cardiovascular mortality, myocardial infarction, disabling stroke and conversion to surgery per VARC definitions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Endpoints * Freedom from composite MAE at three (3), six (6) and twelve (12) months * Individual 30-Day event rates for the following: cardiovascular mortality, procedure related death, non-cardiovascular mortality, myocardial infarction, disabling stroke, non-disabling stroke, transient ischemic attack (TIA), conversion to surgery, life-threatening, major and minor bleeding, stages 1-3 acute kidney injury and major and minor vascular complications per VARC definitions * Number of events and percentage of Subjects for all individual adverse events related to the System or procedure at 30 days, three (3), six (6) and twelve (12) months Hemodynamic Efficacy Hemodynamic improvement at 30 days, three (3), six (6) and twelve (12) months compared to Baseline. The Bioprosthesis will be assessed by echocardiography for reduction in mitral regurgitation by quantitative measures (e.g. PISA, vena contracta width, EROA, regurgitant volume and fraction), as well as overall MR grade. Functional Improvements Functional improvements at 30 days, three (3), six (6) and twelve (12) months as compared to Baseline for New York Heart Association (NYHA) classification, Exercise tolerance (Six Minute Walk Test) and Quality of Life evaluation (Kansas City Cardiomyopathy Questionnaire). Acute Device/Procedural Success Acute device/procedural success is defined as meeting all the following: successful transapical access, successful delivery and deployment of the Bioprosthesis and retrieval of the Catheter, correct positioning of the Bioprosthesis at the proper anatomical location to achieve Grade 2+ or less MR following the implant procedure, no clinically-significant LVOT obstruction (pressure gradient * 20 mmHg) and no bleeding requiring re-intervention for apical repair. | — |
Countries
The Netherlands
Outcome results
None listed