Medtronic Launches Clinical Test To Develop Endowment Of Anxiety For Implantable Defibrillator Patients
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Medtronic, Inc (NYSE: MDT) announced the begin of the Shock-Less clinical trial. This research testament establish ways physicians can emend the genius of interest for patients completed optimal application of device-based tools designed to reduce unnecessary shocks in patients with implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) devices. Specifically, the Shock-Less study aims to make evidence that will increase the application of programming tools that cut unnecessary shocks including features on Medtronic devices, such as Medtronic's exclusive Lead Integrity Alert™ (LIA) and Anti-Tachycardia Pacing (ATP) During Charging™.
"Medtronic has pioneered the advances in shock diminution technology, supported by doozer randomized clinical trials, in the at the end several years; in fact, with current Medtronic programming and technology, closeness of shocks can be reduced by more than 63 percent," said Marshal Stanton, M.D., vise head of the state of clinical research for the Cardiac Rhythm Disease Management career at Medtronic. "We are dedicated to supporting the apply of those innovative programming tools with scientific research and education that will maintenance physicians deliver the best possible therapy for their patients."
While appropriate defibrillation therapy is proven to saves lives, futile shocks can be reduced in many ways:
- Using proprietary slogan programming for Medtronic's Anti-Tachycardia Pacing (ATP) During Charging to deliver painless pacing pulses to safely and effectively terminate dangerous ventricular tachyarrhythmias;
- Using Medtronic exclusives Wavelet™ SVT in unmarried chamber ICDs and Medtronic's PR Logic® in dual chamber ICDs to dilute shocks that may be delivered due to emotions rhythms for which therapy is chance (supraventricular tachycardias or non-sustained ventricular tachycardias);
- Using the Medtronic exclusive Lead Goodness Alert, the first continual ICD monitoring technology that alerts clinicians and makes real-time device changes to decrease the feasible of inappropriate therapy that may determination from fractured leads.
- Maximizing device programming detection and therapy parameters to reduce shocks for non-sustained arrhythmias in Medtronic devices with short and consistent charge times.
"Despite the evidence, physicians are not maximizing the clinically proven programming tools to help abbreviate fortuitous shocks for their patients," said Avi Fischer, M.D., principal trial investigator and assistant professor of Medicine and director of Pacemaker and Defibrillator Therapy at Mount Sinai Medical Centre in New York. "Our aim is to dossier the differences in the journey these devices are programmed and deduce the barriers to using this proven therapy. We aspiration to greater understand how outcomes and patient authority can be improved buttoned up shock reduction."
Physicians in the study will cop customized reports showing the reasons patients received shocks and analysis on how consistently their patient's devices are programmed using the recent clinical evidence as compared to others in their region, and study-wide. Additionally, the evaluation is also designed to show how physicians change their device programming practices after shocks are delivered.
About Medtronic's Shock-Less Trial
The prospective, individuality improvement probation will enrol approximately 2,500 subjects at environing 125 U.S. and Canadian medical centers. Medtronic implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) patients will be followed in the study for at least two years. Facts will be gathered from device downloads as beefy as washed-up Medtronic CareLink® Network transmissions, the industry's largest remote monitoring network that currently allows more than 350,000 Medtronic patients worldwide to send cardiac device information automatically to else than 3,000 clinics in 20 countries.
Medtronic also will collect performance data on Medtronic's proprietary shock reduction tool, Example Integrity Alert™ (LIA); LIA is the exclusive non-stop ICD monitoring technology that offers at least three days fresh warning in three absent of four defibrillator patients with lead fracture. It safely and automatically increases the number of intervals required to detect VF (following detection of a edge fracture) to avoid treating lead fractures as VF.
LIA is available worldwide on Medtronic ICD and CRT-D devices. The latest LIA history for the newest portfolio of Optics 3D™ devices will be available in the U.S. in the prospect months.
Medtronic Shock Decrease Research Medtronic continues to bestow the broadest portfolio of scientific research in the environment of shock reduction, including:
- ADVANCE III (Avoid Delivering Therapies for Non-Sustained Arrhythmias in ICD Patients III) is an happening check to halt whether Medtronic 's Anti-Tachycardia Pacing (ATP) During Charging and extending the interval to detect and treat arrhythmias safely, can lower the necessity for shock therapy in all ICD-indicated patients.
- ADVANCE CRT-D (ATP Delivery for Painless ICD Therapy in CRT-D) showed that ATP for hastily ventricular tachycardias is protected and effective in CRT candidates, and patients with coronary artery disease benefit bounteous from biventricular ATP.
- ADVANCE-D (ATP Delivery for Painless ICD Therapy) is an ongoing proof comparing clashing ATP therapies to optimize success of painless therapies for ventricular tachyarrhythmias in patients with ICDs.
- COMFORT (Concept of Optimal Administration of Ventricular Fibrillation or Actual Fast Ventricular Tachycardia) is evaluating the efficacy and safety of ATP and low energy cardioversion for ventricular arrhythmias in patients with ICDs.
- EMPIRIC (Comparison of Empiric to Physician-Tailored Programming of Implantable Cardioverter-Defibrillators) proved that straightaway standardized Medtronic device settings are as sheltered and able as individual, physician-tailored device settings to reduce shocks.
- ENTRUST originally demonstrated the safety and efficacy of ATP During Charging, which delivers painless ATP therapy during capacitor charging and prevents delay of shock therapy when needed.
- PainFREE Rx and PainFREE Rx II (Pacing Fast Ventricular Tachycardia Reduces Shock Therapies) showed that three out of four shocks are eliminated using ATP, thus improving aspect of life.
- PREPARE (Proven Shock Reduction for Primary Prevention Patients) showed a 63 percent alleviation in extrinsic shocks for primary prevention patients.
- GEM DR showed that Medtronic's PR Logic® dual chamber rhythm detection resulted in besides accurate tachyarrhythmia therapy to help divide inappropriate shocks.
- Meaningful (Registry on Left Ventricular Dysfunction and Non-ischemic Ventricular Tachyarrhythmias) showed that extending the hour an ICD takes to detect and treat arrhythmias is safe and direct in reducing shocks for non-ischemic primary prevention heart failure patients.
- WAVE (Worldwide Manipulate of Marquis VR Enhancements) showed that the Medtronic exclusive Wavelet™ SVT discrimination aspect in single hospital ward ICDs reduced inappropriate therapy by 78 percent.
- Pleasure (Survey on Antitachycardia Pacing Strategy for the Termination of Fast Ventricular Tachycardia in Japanese Implantable Cardioverter-Defibrillator Population) will determine the efficacy of ATP to painlessly terminate ventricular tachycardias in Japanese ICD and CRT-D patients.
Medtronic and the University of Minnesota are hosting an educational session, "Unnecessary Shocks: What Are You Doing?," on shock reduction during Affection Rhythm 2009, the annual congress of the Feelings Rhythm Kingdom at 7 p.m. ET Wednesday, May 13, 2009, at the Boston Marriott Copley City in Boston. Pre-registration is required.
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