NIPS-ICDNon-invasive Programmed Stimulation to Identify High-risk Patients With Implanted Cardioverter-defibrillator
Sustained or hemodynamically unstable arrhythmia induction during non-invasive programmed stimulation
Étude de screening
Résumé
Date de début de l'étude : 1 novembre 2013
Date à laquelle le premier participant a commencé l'étude.Some studies have shown that factors predicting ventricular tachycardia (VT) or ventricular fibrillation (VF) recurrences and consequently ICD interventions, include patient's age, New York Heart Association class heart failure, left ventricular ejection fraction (LVEF), the presence of atrial fibrillation (AF), the QRS complex width, and the status of renal function. However, the accuracy of these parameters is limited and other variables that may identify vulnerable patients are sought. This may have important clinical implications because such patients could receive more aggressive antiarrhythmic therapy or may undergo prophylactic ablation of arrhythmia substrate to prevent the occurrence of arrhythmias and ICD discharges. Indeed, some studies suggested that it might be worth to perform prophylactic ablation of VT in patients with previously implanted ICD, however, this approach has not entered into daily clinical practice. One of the methods of risk stratification for sudden cardiac death which has been used for many years, is programmed ventricular stimulation (PVS). This is an invasive study assessing the likelihood of VT or VF induced by stimulation to occur. This test has been also used in order to qualify for prophylactic ICD implantation in patients with LVEF 31-40% and non-sustained VT in ambulatory ECG. The primary disadvantage of PVS is its invasiveness. Modern ICDs are relatively complex devices with a number of functions, including the possibility to perform NIPS with implanted electrode located in the right ventricle. NIPS is readily available, inexpensive, minimally burdening ICD battery and less disturbing to the patient, because it does not require any invasive procedure. Some studies suggested that appropriate interventions occur more frequently in patients who had ventricular arrhythmias induced by NIPS, but prognostic significance of NIPS has not yet been determined. One of the first NIPS-related studies demonstrated that VF/VT inducibility during the test of the device can help to optimize ICD programming, however, predictive value of NIPS had not been studied at that time. In another study, one of the first and few on the prognostic value of NIPS, it has been shown that induction of monomorphic, especially relatively slow VT (cycle length> 280ms) was prognostic for recurrence of arrhythmias. This study was relatively small, the distribution of etiology had not been considered, and some of the results were surprising, eg. previous myocardial infarction of inferior wall, rather than the anterior wall, predicted altered outcome, while LVEF had no prognostic value. In addition, these studies had been carried out many years ago, when the use of primary angioplasty for acute myocardial infarction was low, and therefore the clinical characteristics of the patient groups from that period are different than those of contemporary patients.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.150 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Screening
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
Inclusion Criteria: \- patients with an ICD implanted both for primary and secondary prevention, regardless of etiology, who are followed in the outpatient clinic of our center, and who do not meet the exclusion criteria Exclusion Criteria: * lack of consent for NIPS * decompensated heart failure * unstable angina * persistent/long standing AF without effective anticoagulation (risk of sinus rhythm return during NIPS) * thrombus in the left ventricle * appropriate device interventions during the 40 days prior to planned NIPS * pacing/sensing problems
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site