Ela Medical S.a.

Remi Nitzsche

Marcel Limousin

Jean-Luc Bonnet

Christine Henry

Nicolas Iscolo

Peter Jacobson

Daniel Kroiss

A process for managing data collection for clinical protocols and investigations (registry) relating to the use of active implantable medical devices, such as pacemaker, cardiovertor, defibrillator and multisite devices. This process is characterized by the following stages:

Managing data for clinical protocols relating to the use of active implantable medical devices

An active implantable medical device, particularly a cardiac pacemaker, defibrillator and/or cardiovertor capable of detecting the spontaneous depolarisation of the myocardium and determining the instant of its occurrence, which device detects the spontaneous depolarisation (10) of the myocardium through processing of a cardiac signal (E), delivers an information (t) of occurrence of a depolarisation and conditionally discriminates, preferably during consecutive limited time intervals ([t-50, t+200]), a unique characteristic of the cardiac signal giving a temporal information (T.sub.1, T.sub.2, T.sub.3) on the instant of occurrence of the depolarisation. The unique characteristic can particularly be a predetermined singularity of the cardiac signal such as an extreme, particularly the extreme negative, of the first derivative (dE/dt) of the cardiac signal.

Determining the rhythm of the spontaneous depolarization of the

An active implantable medical device of the defibrillator/cardiovertor type with advanced tachycardia discrimination in which the device monitors the atrial and ventricular activity, suspects and confirms the presence of tachycardia episodes in the monitored activity, and operates a classification algorithm to discriminate between ventricular tachycardias and supra-ventricular tachycardias according to predetermined criteria and a given adjustment of these criteria, and to authorize the releasing of a shock therapy defibrillation, and/or cardioversion and/or anti-tachycardia ventricular stimulation in the presence ventricular tachycardias and to inhibit delivery of a shock therapy in the presence of a supra-ventricular tachycardias, or instead to release an atrial therapy. The advanced discrimination modifies the classification operation by being able to add temporarily one or more criterion and/or to modify temporarily the adjustment of an existing (predetermined) criterion in case of a suspected atrial fibrillation. Added criterion include particularly a supplementary research criterion of short and/or long RR intervals, which are significantly distanced from a zone of RR interval stability, which significantly distanced zones are, for example, separated from the RR interval stability zone by a predetermined width interval, which width interval is identical on both sides of the RR interval stability zone.

Method and apparatus for advanced tachyarrhythmia discrimination

An active implantable medical device of the defibrillator/cardiovertor type with an improved tachycardia discrimination for utilizing the delivery of a therapy of defibrillation and/or cardioversion and/or antitachycardia stimulation in the ventricle and/or atrium. The atrial and ventricular activity is monitored, and suspected tachycardia episodes in the monitored activity is tested and confirmed, the stability of RR intervals and the stability of associated PR interval are analyzed. The classification discriminates tachycardias detected as between ventricular tachycardias and supra-ventricular tachycardias, and authorizes delivery of a shock therapy in the presence of a confirmed ventricular tachycardias, or inhibits delivery of a shock therapy in response to a confirmed supra-ventricular tachycardia. Where appropriate, the classification also releases an atrial therapy. The improvement concerns determining the presence or the absence of a rapid acceleration of the rhythm of RR intervals, and determining, if necessary, the origin (atrial or ventricular) of such acceleration, in the case of the detection of unstable RR intervals for discriminating tachycardias.

Methods and apparatus for improved tachycardia discrimination in an

Control of an anti-tachycardia device such as a defibrillator to apply a preselected programmed therapy in the event of ventricular tachycardia. The control includes comparison of the atrial and ventricular rhythms, and examination of the criteria of stability of the P-R intervals, of the stability of the R-R intervals, and of the acceleration of the ventricular rhythm subsequent to an atrioventricular desynchronization, thereby to ensure control of the antitachycardia device solely in the event of ventricular tachycardia.

Apparatus and method of control for an implanted anti-tachycardia device

The difference between the divergences between the determined PR and RR intervals (dPR-dRR) is measured, cycle by cycle, and compared to two selected thresholds S1 and S2. If the difference exceeds threshold S1, a signal corresponding to a ventricular tachycardia is triggered. If the difference is below threshold S2, a signal corresponding to a supraventricular tachycardia related signal is triggered. The trigger signals may be used to control the therapeutic treatment of an implantable tachycardia treatment device accordingly.

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Gambais, France

Remi Nitzsche