Health Condition 1: I509- Heart failure, unspecified
Conditions
Interventions
Intervention1: Myclipâ?¢ Transcatheter Edge to Edge Repair (TEER) System: The Myclip Delivery System (MDS) is indicated for the percutaneous repair of
symptomatic mitral due to primary [degenerative M
Sponsors
Meril Lifescience Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patient or their legally acceptable representative (LAR) has provided written informed consent Patients with symptomatic mitral regurgitation
Exclusion criteria
Exclusion criteria: Calcification at clip grasping zone Presence of IVC filter Previously implanted atrial septal occluder which prevents free exchange of system from RA to LA Left atrial height less than 3.0 cm Presence of LA/LAA clot Severe tricuspid regurgitation with Right Ventricular Failure Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen Rheumatic mitral valve disease Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study Pregnant and lactating female patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from Mitral Valve (MV) surgery MR reduction grade 2 Repeat hospitalization due to heart failureTimepoint: 30 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality Myocardial Infarction All stroke Acute kidney injury Non-elective cardiac surgery for device related complication NYHA) Functional ClassificationTimepoint: 30 days, 6 months, 1 year | — |
Countries
India
Contacts
Public ContactMr Imrankhan Lohani
Meril Lifescience Pvt Ltd
Outcome results
None listed