functional mitral regurgitation heart failure
Conditions
Interventions
The procedure to implant the Accucinch System involves obtaining vascular
access from the femoral artery, advancing catheters into the heart retrograde
crossing the aortic valve and gaining access t
Sponsors
Guided Delivery Systems, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Safety through 30 days assessed by the rate and severity of major adverse cardiac and cardiovascular events (MACCE) and device and procedure related major adverse events (MAE). | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy will be assessed by one or more of the following measures: • Reduction in MR acutely, and at 30 days and 6M follow-up, as measured by echocardiography • Evidence of left ventricular reverse remodeling during follow-up, as measured by echocardiography Symptom improvement (NYHA Class, 6-minute walk test, and/or QoL) Feasibility: Ability to establish access to the mitral subannular groove, to deploy the anchors, to reshape the mitral apparatus, to deploy the lock, and to cut the cinching cable. Safety: MAE through 6 months. | — |
Countries
Netherlands
Outcome results
None listed