Introducing the COAPT Trial
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- Imogene Valerie Harper
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1 physician INFORMATION Eligible patients Symptomatic functional mitral regurgitation 3+ Not suitable candidates for open mitral valve surgery NYHA functional class II, III, or ambulatory IV Introducing the COAPT Trial An assessment of percutaneous mitral valve repair in patients with functional mitral regurgitation who are not appropriate for mitral valve surgery
2 Primary endpoints COAPT Trial design overview Efficacy Device group (MitraClip device) 1 week (post-treatment phone contact) Randomize 1:1 30 days 6, 12, 18, 24 months 430 patients enrolled at up to 85 U.S. sites and Canada Control group (No device) clinical and echo Follow-up a Annually thereafter, for a total of 5 years a TEST: 6MWT, QoL, NYHA functional class, TTE, BNP/nT-pro BNP level, modified Rankin Scale Per protocol 6.0 COAPT Physician Information Brochure version 1.0 October 24, 2014 Recurrent heart failure (HF) hospitalizations through 24 months (analyzed when the last subject completes 12 months of follow-up) Safety Composite of Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, and any device related complications requiring non-elective cardiovascular surgery at 12 months Secondary endpoints Efficacy Mitral regurgitation severity at 12 months Change in 6-minute walk test at 12 months Change in quality of life at 12 months Change in Left Ventricular end-diastolic volume at 12 months NYHA functional class I/II at 12 months Hierarchical composite of death and recurrent HF hospitalization Recurrent hospitalizations all-cause Safety Composite of all-cause death, stroke, MI, or non-elective cardiovascular surgery for device related complications at 30 days post-procedure in the MitraClip group All-cause mortality at 12 months
3 Patient inclusion/exclusion criteria Key inclusion criteria Symptomatic functional MR ( 3+) of either ischemic or nonischemic etiology Subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure Not an appropriate candidate for open mitral valve surgery in the judgment of the the local site heart team (CT Surgeon and HF Specialist Investigators) NYHA functional class II, III, or ambulatory IV At least 1 hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected BNP 300 pg/ml or corrected NT-proBNP 1500 pg/ml measured within 90 days prior to subject registration Left Ventricular Ejection Fraction (LVEF) is 20% and 50% Left Ventricular End Systolic Dimension (LVESD) is 70 mm Key exclusion criteria Untreated clinically significant coronary artery disease requiring revascularization Coronary artery bypass grafting (CABG) within prior 30 days Percutaneous coronary intervention within prior 30 days Tricuspid valve disease requiring surgery Aortic valve disease requiring surgery Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use Cerebrovascular accident within prior 30 days Severe symptomatic carotid stenosis (> 70% by ultrasound) Carotid surgery within prior 30 days Mitral valve orifice area < 4.0 cm 2 Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip Refer your eligible patients to a COAPT Trial site to enroll. Per protocol 6.0 COAPT Physician Information Brochure version 1.0 October 24, 2014
4 The MitraClip device is a percutaneously implanted mechanical clip. The device grasps and coapts the mitral valve leaflets resulting in fixed approximation of the mitral leaflets throughout the cardiac cycle. Placement of the implant is performed without the need for arresting the heart or cardiopulmonary bypass. B Closed double orifice A Open double orifice 1 An implantable clip (A) is delivered into the heart by a catheter (B), via the femoral vein. 2 Once the clip is put into place on the mitral valve, the catheter is removed. CAUTION: Investigational device. Limited by federal (U.S.) law to investigational use only. 3 The clip becomes a permanent implant in the heart, allowing the valve to close tightly and restore normal blood flow through a double-orifice valve.
5 About the COAPT Trial The COAPT Trial is the first prospective, randomized, parallelcontrolled clinical evaluation of the MitraClip device for the treatment of clinically significant functional mitral regurgitation in symptomatic heart failure patients that are not appropriate for mitral valve surgery. The multicenter study will examine the safety and efficacy of the MitraClip device used in addition to standard care for mitral regurgitation and heart failure (device group) compared to treatment with standard care alone (control group). The trial will generate important clinical and economic data to support reimbursement and the development of treatment guidelines.
6 The COAPT Trial is approved Join us in the search for treatment alternatives for patients with functional mitral regurgitation who are not appropriate for mitral valve surgery. Please consider enrolling your eligible patients. For more information on the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) Trial, visit (keyword COAPT ). Abbott Vascular 3200 Lakeside Dr., Santa Clara, CA USA, Tel: COAPT address MitraClip is a registered trademark of the Abbott Group of Companies. Per protocol 6.0 COAPT Physician Information Brochure version 1.0 October 24, Abbott. All rights reserved.
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