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NIPS-ICDNon-invasive Programmed Stimulation to Identify High-risk Patients With Implanted Cardioverter-defibrillator

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Qué se está evaluando

Sustained or hemodynamically unstable arrhythmia induction during non-invasive programmed stimulation

Procedimiento
Quiénes están siendo reclutados

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Cómo está diseñado el estudio

Estudio de Detección

Intervencional
Inicio del estudio: noviembre de 2013
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Resumen

Patrocinador PrincipalSt. Joseph's Centre, Poland
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de noviembre de 2013

Fecha en la que se inscribió al primer participante.

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.

Título OficialNon-invasive Programmed Stimulation to Identify High-risk Patients With Implanted Cardioverter-defibrillator
NCT02373306
Patrocinador PrincipalSt. Joseph's Centre, Poland
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 150 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Detección

Los estudios de detección prueban nuevos métodos para detectar enfermedades o factores de riesgo en etapas tempranas, antes de que aparezcan los síntomas. Esto permite identificar problemas de salud cuando aún pueden tratarse con mayor eficacia.


Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Criterios

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 Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Comparador Activo
Patients who had sustained or hemodynamically unstable arrhythmia induction during non-invasive programmed stimulation.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

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Este estudio tiene una ubicación

Suspendido

St. Joseph's Centre

Rzeszów, PolandAbrir St. Joseph's Centre en Google Maps
Completado1 Centros de Estudio