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Post-Market Clinical Trial Will Assess Superiori-ty of the AdaptivCRT Feature Compared to Standard CRT

Medtronic, Inc. has announced the first implants in a clinical trial that will compare patient and healthcare system outcomes - including patient mortality and hospitalizations - in heart failure patients who have cardiac resynchronization therapy (CRT) devices with the AdaptivCRT feature enabled versus patients receiving standard CRT. The AdaptResponse trial will assess the superiority of the AdaptivCRT algorithm, which preserves normal heart rhythms and automatically adjusts to patients' needs to customize therapy; it is expected to be the largest trial of CRT to date, enrolling approximately 3,000 patients worldwide.

The primary endpoint of the AdaptResponse trial is a combination of all-cause mortality and the rate of medical intervention for worsening heart failure (decompensation). The trial also will examine the incidence of atrial fibrillation (AF) in enrolled patients; other secondary endpoints will assess patient quality of life measures as well as cost-effectiveness of CRT devices with the AdaptivCRT feature relative to standard CRT. Patients will receive a CRT-pacemaker or CRT-defibrillator equipped with the AdaptivCRT algorithm, and will be randomized 1:1 to either treatment (aCRT ON) or control (aCRT OFF) groups. Patients will be followed at three and six months after randomization, and then every six months until trial closure.

Patients will be enrolled at up to 200 centers in Europe, Latin America, the Middle East, Australia, Canada, India, Japan, South Korea, Taiwan and the U.S. The first implants in the trial were performed by Mark Castellani, M.D., at Sparrow Hospital in Lansing, Mich., and by Edward J. Schloss, M.D., at The Christ Hospital in Cincinnati. Bruce Wilkoff, M.D., director of Cardiac Pacing and Tachyarrhythmia Devices at the Cleveland Clinic, is chair of the AdaptResponse trial's steering committee.

About the AdaptivCRT Algorithm The AdaptivCRT algorithm is the first significant advance to improve patient response rates to CRT since the advent of the therapy more than 10 years ago. The benefits of the algorithm were demonstrated in the Adaptive CRT Trial, a prospective, multicenter, randomized, double-blind clinical trial. Key findings from the original trial, sub-analyses and economic models recently presented at Heart Rhythm 2014 and Cardiostim 2014 showed:

  • For patients with normal AV conduction, AdaptivCRT showed an increase in CRT response rate of 12 percent1 at six months
  • Patients with AdaptivCRT demonstrated a 21 percent reduction in heart failure hospitaliza-tions2 as compared to historical CRT trials
  • Patients with the AdaptivCRT technology demonstrated a 46 percent reduced risk of AF3, and a 61 percent lower risk of AF-related problems4
  • AdaptivCRT demonstrated a reduction in 30-day hospital readmissions for heart failure of 47 percent5

In the U.S., approximately 5.1 million people suffer from heart failure6 and the estimated cost for treating heart failure is approximately $40 billion per year.7 Worldwide, more than 23 million people suffer from heart fail-ure.8,9  The disease consumes intensive resources during hospitalizations and continues to cause problems following hospital stays, with six month readmission rates of 50 percent10-12 and mortality rates of approximately 30 percent.13 Repeated heart failure hospitalizations also are associated with increased mortality.

"Medtronic is committed to improving the lives of people with heart failure at every stage of their care, including those who can benefit from cardiac resynchronization therapy," said David Steinhaus, M.D., vice president and general manager, Heart Failure, and medical director for the Cardiac Rhythm Disease Management business at Medtronic. "With the AdaptivCRT algorithm improving patient response to CRT, we see fewer heart failure complications, and fewer burdens imposed on patients and healthcare resources."

1 Birnie D, Lemke B, Aonuma K, et al. Clinical outcomes with synchronized left ven-tricular pacing: Analysis of the adaptive CRT trial. Heart Rhythm. September 2013;10(9):1368-1374.
2 Tarab AD, Dougher CE, Rogers TB, et al. Budget impact of selecting cardiac resynchronization therapy (CRT) devices with adaptive ("aCRT") programming algorithms under the United States Medicare Payment Setting. Value in Health. November 2012;15(7):A349.
3 Martin D, et al. Can Adaptive Cardiac Resynchronization Therapy Reduce Atrial Fibrillation Risk? Circulation. 2013;128(22S):A17740.
4 Lemke B, et al. Atrial Fibrillation Resource Use with an Adaptive Device Algorithm. June 2014, Cardiostim, Nice, France.  
5 Starling RC, et al. Impact of Novel Adaptive Optimization Algorithms on 30-day Readmissions: Evidence from the Adaptive CRT Trial. Heart Rhythm 2014;11(5)(suppl):S155
6 Go AS., Mozaffarian D., Roger VL., Benjamin EJ., Berry JD., et al. Heart disease and stroke statistics-2013 update: a report from the American Heart Association. Circulation 2013;127:e6-e245
7 American Heart Association. Heart Disease and Stroke Statistics-2010 Update. Circulation. Available at http://www.americanheart.org/presenter.jhtml?identifier=3000090
8 Lloyd-Jones D, et al. Heart disease and stroke statistics - 2010 update: a re-port from the American Heart Association. Circulation. 2010; 121:e46-e215.
9 McMurray JJ, Petrie MC, Murdoch DR, Davie AP. Clinical epidemiology of heart failure: public and private health burden. Eur Heart J. 1998; 19 (Suppl. P): P9-P16.
10 Krumholz HM, Merrill AR, Schone EM, Schreiner GC, Chen J, Bradley EH, Wang Y, Wang Y, Lin Z, Straube BM, Rapp MT, Normand SL, Drye EE. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009;2:407- 413
11 Joynt KE, Jha AK. Who has higher readmission rates for heart failure, and why? Implications for efforts to improve care using financial incen-tives. Circ Cardiovasc Qual Outcomes. 2011;4:53-59.
12 Chun S, Tu JV, Wi-jeysundera HC, Austin PC, Wang X, Levy D, Lee DS. Lifetime analysis of hospitalizations and survival of patients newly admitted with heart failure. Circ Heart Fail. May 2, 2012. doi 10.1161/ CIRCHEARTFAILURE.111.964791. http://circheartfailure.ahajournals.org. Accessed April 19, 2012.
13 Loh J, et al. Temporal Trends in Treatment and Outcomes for Ad-vanced Heart Failure With Reduced Ejection Fraction From 1993-2010. Circulation: Heart Fail-ure. 2013; 6:411-419. Available at http://circheartfailure.ahajournals.org/content/6/3/411.full.html?ijkey=7BfsyD7wNlUfm8t&keytype=ref

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