www.biotronik.com
BIOTRONIK’s excellent quality devices and therapy solutions are clinically proven by robustly designed and managed clinical trials - from one of the most impressive programs in the CRM industry with more than 50 studies currently ongoing. Our comprehensive portfolio of major clinical trials supports our quality solutions and is aimed at making a real difference in advancing effective, efficient, comprehensive healthcare delivery. Our landmark trials address important unanswered clinical questions and have the potential to impact therapy guidelines.
Investing in meaningful clinical research of clear significance and rigorously running clinical trials to achieve unequivocal endpoint conclusions, BIOTRONIK demonstrates commitment and leadership in clinical excellence.
BIOTRONIK Landmark CRM Clinical Trial Programs
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The COMPAS trial is the first and only large-scale pacemaker patient study to demonstrate that daily automatic remote monitoring with BIOTRONIK Home Monitoring® is safe and effective in the long-term and significantly reduces hospitalizations for atrial arrhythmias and related stroke. The results support safe and efficient long-term pacemaker follow-up with exception-based care, based on reliable early detection enabling earlier intervention, and can change the way physicians care for their pacemaker patients. |
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| No. of patients No. of centers Status Results published in: European Heart Journal |
538 43 completed November 2011 |
| Publications: Mabo P, Victor F, Bazin P, Ahres S, Babuty D, Da Costa A, Binet D, Daubert JC.. A Randomized Trial of Long-Term Remote Monitoring of Pacemaker Recipients (The COMPAS Trial). European Heart Journal 2011; doi: 10.1093/eurheartj/ehr419European Heart Journal 2011; doi: 10.1093/eurheartj/ehr419 |
| This study is a multi-center, prospective and randomized trial. The primary objective of this study is to demonstrate that the use of the BIOTRONIK Home Monitoring system (HM) can safely reduce the number of regularly scheduled office follow-up visits, compared to the conventional method of implantable cardioverter defibrillator (ICD) follow-up. |  |
| No. of patients No. of centers Status Results published in Circulation1: Circulation Arrhythmia & EP2: |
1,450 102 closed Jul.2010 Aug. 2010 |
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Publications: Varma N, Michalski J, Epstein AE, Schweikert R. Automatic Remote Monitoring of Implantable Cardioverter-Defibrillator Lead and Generator Performance: The TRUST Trial. Circulation Arrhythm Electrophysiol 2010;3;428-436 |
| The IMPACT Study will investigate the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in patients with implanted dual-chamber defibrillators or cardiac resynchronization therapy devices. |  |
| No. of patients No. of centers Status Design paper published in: American Heart Journal |
2,718 100 ongoing Sep. 2009 |
| Publications: Ip J, Waldo A, Lip G, Rothwell P, Martin D, Bersohn M, Choucair W, Akar J, Wathen M, Rohani P, Halperin J. Multicenter randomized study of anticoagulation guided by remote rhythm monitoring in patients with implantable cardioverter-defibrillator and CRT-D devices: Rationale, design, and clinical characteristics of the initially enrolled cohort: The IMPACT study. Am Heart J 2009;158:364-370.e1 |
| Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. The incidence and prevalence of AF increase exponentially with increasing age and AF is associated with higher mortality, more frequent hospitalization, and lower quality of life. Furthermore, AF is often associated with heart failure. The majority of AF is initiated by ectopic foci found primarily in the pulmonary veins. It was shown that catheter ablation of those veins could eliminate episodes of AF. In patients with heart failure, catheter ablation could improve cardiac function, symptoms and quality of life. It remains still unknown whether AF ablation is more effective than conventional treatment in terms of mortality and morbidity. |  |
| No. of patients No. of centers Status Design published in: PACE |
420 50 ongoing August 2009 |
| Publications: Marrouche N, Brachmann J. Catheter Ablation versus Standard Conventional Treatment in Patients with Left Ventricular Dysfunction and Atrial Fibrillation (CASTLE-AF) - Study Design. PACE 2009; 32(8): 987–994. |
| The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a planned system modification or with a planned system modification. Secondarily, this study aims to compare the influence of baseline variables contributing to the all-cause complication rates for subjects undergoing generator replacement. |  |
| No. of patients No. of centers Status Results published in: Circulation |
1,750 71 completed Oct. 2010 |
| Publications: Poole J, Gleva M, Mela T, Chung M, Uslan D, Borge R, Gottipaty V, Shinn T, Dan D, Feldman L, Seide H, Winston S, Gallagher J, Langberg J, Mitchell K, Holcomb R. Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures. Results from the REPLACE registry. Circulation 2010;122:1553-1561. |
