A Study of Percutaneous Left Ventricular Reshaping of Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve LV Function Using the Accucinch System.
- Conditions
- 10046973functional mitral regurgitationheart failure
- Registration Number
- NL-OMON39112
- Lead Sponsor
- Guided Delivery Systems, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
1. Age >= 18 years
2. Subjects with clinically significant mitral regurgitation (MR 2+ and above)
3. Ejection Fraction >= 25%
4. Stable cardiac medical regimen for heart failure for at least 1 month
5. Stable NYHA Classification for at least 1 month
6. Subject is eligible for cardiac surgery
7. The subject has been informed of the nature of the study, agrees to its provisions, and has provided written consent
1. Myocardial infarction within 90 days of the intended treatment with the device
2. Prior surgical, transcatheter, or percutaneous mitral valve intervention
3. Any intervention for coronary artery disease (CAD) within the last 30 days prior to treatment, or unrevascularized multivessel coronary disease.
4. Hemodynamic instability or the need for emergent surgery
5. Non-ambulatory NYHA Class IV symptoms of heart failure or subjects requiring IV inotropic support
6. Subjects in whom sufficient quality of echocardiography (TTE and TEE) cannot be obtained
7. Echocardiography evidence of primary mitral valve disease causing MR or MS
8. Evidence of mitral valve stenosis with an estimated valve area less than 3.0 cm²
9. Mitral valve prosthesis or pathology that would prevent adequate function of the GDS Accucinch System
10. Estimated GFR of <30ml/min/1.73m²
11. Greater than mild mitral annular calcification observed by fluoroscopy
12. Presence of aortic valve prosthesis
13. Moderate to severe aortic valve stenosis or calcification observed by echocardiography or fluoroscopy
14. Severe aortic arch calcification or mobile aortic atheroma observed by echocardiography or fluoroscopy
15. Active bacterial endocarditis
16. History of bleeding diathesis or coagulopathy
17. History of stroke within the prior 6 months
18. Subjects in whom anticoagulation is contraindicated
19. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
20. Concurrent medical condition with a life expectancy of less than 12 months
21. Currently participating in an investigational study
22. Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, immunological abnormalities, and hematological abnormalities)
23. Subjects with indication for concomitant surgery such as coronary artery bypass graft (CABG), aortic valve reconstruction or replacement, tricuspid repair or replacement, left ventricular remodeling surgery and congenital repair
24. Any cardiac resynchronization therapy within the last 3 months prior to treatment
25. Subjects on high dose steroids or immunosuppressant therapy
26. Female subjects who are pregnant, of child bearing potential or lactating
27. Subjects who are unable or unwilling to comply with the follow-up schedule and requirements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety: Safety through 30 days assessed by the rate and severity of major<br /><br>adverse cardiac and cardiovascular events (MACCE) and device and procedure<br /><br>related major adverse events (MAE).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy will be assessed by one or more of the following measures:<br /><br>• Reduction in MR acutely, and at 30 days and<br /><br>6M follow-up, as measured by echocardiography<br /><br>• Evidence of left ventricular reverse remodeling during follow-up, as measured<br /><br>by echocardiography<br /><br>Symptom improvement (NYHA Class, 6-minute walk test, and/or QoL)<br /><br>Feasibility: Ability to establish access to the mitral<br /><br>subannular groove, to deploy the anchors, to reshape the mitral<br /><br>apparatus, to deploy the lock,<br /><br>and to cut the cinching cable.<br /><br><br /><br>Safety: MAE through 6 months.</p><br>