J Am Coll Cardiol ; Editorial: Carabello BA. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med ; Principal Findings: Overall, patients were enrolled. Interpretation: Among patients with severe mitral regurgitation, repair with a percutaneous mitral valve clip is feasible.
Presented by Dr. P olypoidal choroidal vasculopathy PCV is characterized by aneurysmal polypoidal dilatations and branching vascular network, and it is a common form of exudative neovascular age-related macular degeneration nAMD in the Asian population. In a previous Retinal Physician article, we reported the differences between the 2 landmark trials and the treatment outcomes at 12 months.
Prasad Eye Institute in Hyderabad, India. Singh and Chhablani report no related disclosures. Chhablani can be reached via e-mail at jay. Both studies were multicenter, randomized controlled trials with a follow-up period of 2 years. The treatment protocols varied significantly in the 2 studies. It also included PDT, which was administered from 3 months onwards with a minimal interval of 3 months between 2 treatment sessions. After 16 months, 41 patients in the RBZ monotherapy group were eligible to be switched to combination therapy.
Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure. Number of patients who underwent surgical mitral valve repair or replacement after the index MitraClip procedure. It is a summary of re-interventions to place an additional MitraClip Device. Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure.
Defined as how often patients receiving surgery required replacement of the mitral valve. Eligibility Criteria. The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve. Male or Female. Female subjects of childbearing potential must have a negative pregnancy test within seven 7 days before the procedure. The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site.
The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits. Transseptal catheterization is determined to be feasible by the treating physician. In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or presence of ipsilateral deep vein thrombosis DVT.
If leaflet flail is present: Flail Width: the width of the flail segment is greater than or equal to 15 mm, as defined in Section 4. If leaflet tethering is present: a. Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR.
Need for emergent or urgent surgery for any reason. Prior mitral valve leaflet surgery or any currently implanted mechanical prosthetic mitral valve. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic diseased i. History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions. Active infections requiring current 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.
Intravenous drug abuse or suspected inability to adhere to follow-up. Patients in whom transesophageal echocardiography TEE is contraindicated. A known hypersensitivity or contraindication to study or In the judgment of the Investigator, patients in whom the presence of a permanent pacemaker or pacing leads would interfere with placement of the test device or the placement of the test device would disrupt the leads. Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. Meridian, Ste. More Information. Additional Information: Sponsor information. Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients. Epub Aug 4. Evaluation of renal function before and after percutaneous mitral valve repair. Circ Cardiovasc Interv.
National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Device: Percutaneous mitral valve repair using MitraClip implant. Not Applicable. Study Type :. Interventional Clinical Trial. Actual Enrollment :.
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