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Miracle EF Clinical Study (CRT in Heart Failure Patients with LBBB and LVEF 36-50%) Steering Committee: Cecilia Linde , Anne Curtis , Gregg Fonarow , Kerry Lee , William Little , Anthony Tang , Francisco Leyva , Shin-ichi Momomura , and Martin Cowie 1 2 3 4 5 6 7 8 9 Karolinska Institutet, Stockholm Sweden; 2University at Buffalo, Buffalo, NY; 3University of California at Los Angeles; 4Duke University, Durham, NC; 5University of Mississippi, Oxford, MS; 6Victoria Cardiac Arrhythmia Trials , Victoria, BC, Canada; 7Queen Elizabeth Hospital, University of Birmingham, UK; 8Jichi Medical University, Saitama, Japan; 9 The Royal Brompton Hospital, London, UK 1 Patient Criteria • The benefits of CRT for NYHA II-III HF patients with a wide QRS, low LVEF ≤ 35% and optimal medical therapy is established • The benefits are greater with wider QRS duration and/or LBBB, demonstrating the role of electrical dyssynchrony • However, the effect of LVEF on CRT outcomes is less clear. Recent sub-studies indicate that CRT benefit may be present over the full range of reduced LVEF* A 80 70.2 Percent of patients 70 P = 0.23 62.8 60 Under 35 Over 35 50 40 30 18.6 20 17.1 12.7 18.6 10 0 Unchanged Improved B 80 P = 0.23 70 Percent of patients Worsened 57.8 60 Under 35 Over 35 50.8 50 40 34.5 34.9 30 20 14.3 7.6 10 0 > 15% Decrease Unchanged > 15% Increase A) Improved clinical composite score. B) Reduction in left ventricular end systolic volume by 15% or more. There were no significant differences between groups. Methods • Prospective, randomized, controlled, double-blinded, parallel comparison, global, multi-center clinical trial • 2,900 subject to achieve sample of 2,300 implants at up to 275 centers worldwide (up to 200 US) • Event driven study design, 4 interim analyses • Minimum follow-up duration of 24 months or until study closure Identify Potential Subject No (LBBB, NYHA Class II/III, No device) Yes No Further Action Subject Signs Consent Yes Confirm Eligibility and Complete Baseline Testing Yes CRT Implant Yes Subject Randomized 2:1 CRT ON No No No No CRT OFF Subject Exit Objectives Inclusion Exclusion • Chronic heart failure • LVEF between 36% and 50% • LBBB with QRS ≥ 130 ms • Patient is either: – NYHA Class III OR – NYHA Class II, with hospitalization for HF in the last 12 months OR – NYHA Class II, without hospitalization for HF, but with BNP ≥ 250 pg/ml or NT-proBNP > 1,000 pg/ml • Sinus rhythm at time of enrollment • Optimal medical therapy per guidelines for Heart Failure, Ischemic Heart Disease (IHD), Hypertension, and Atrial Fibrillation, as applicable • No additions to or subtractions from non-diuretic heart failure medical therapy within prior 30 days • Indicated for implantable cardioverter defibrillator (ICD) • CRT-P, pacemaker, ICD or CRT-D device implanted • Mechanical tricuspid heart valve • Unstable angina or an acute MI within past 40 days • Coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within the past 90 days • Chronic (permanent) atrial arrhythmias • Cardioversion for atrial fibrillation within the past 30 days • Life expectancy of less than 24 months due to non-cardiac conditions. • < 18 years of age • Significant renal dysfunction • Significant hepatic dysfunction Primary Efficacy: Time to first event will be assessed, defined as: • All-cause mortality, or •H F Event, defined as either: Inpatient hospitalization for HF, or Outpatient event requiring invasive clinical intervention and management for HF (i.e., IV diuretics, ultrafiltration, or equivalent) and overnight stay Primary Safety: System-related complication-free at 6 months > 80% Status Study Status: Enrolling Study Start Date: January 2013 Estimated Study Completion Date: 2018, if full duration of follow-up Contacts Contact: C hristopher Manrodt, Trial Leader [email protected] Sponsor: Medtronic, Inc. (Monitor) 1-Month, 3-Month, and 6-Month Follow-Up 6-Month Follow-Ups Until Study Closure Funding: Medtronic, Inc. ClinicalTrials.gov: NCT01735916 * Chung, et al. Eur J Heart Fail. 2010;12:581-587. UC201402550 EN © Medtronic, Inc. 2013. Minneapolis, MN. All Rights Reserved. Printed in USA. 09/2013 Background