Clinical trial NCT02373306: NIPS to Identify High-risk Patients With ICD
Official title: Non-invasive Programmed Stimulation to Identify High-risk Patients With Implanted Cardioverter-defibrillator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Arrhythmia
Keywords: Risk stratification
ICD intervention
occurrence during one-year follow-up after NIPS
Lead sponsor: St. Joseph's Centre, Poland
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Implantable cardioverter-defibrillator (ICD) is a widely used and effective therapy which reduces the risk of cardiac death in many cardiac diseases, both implanted for secondary and primary prevention. It is known that recurrent arrhythmias and ICD discharges have adverse prognostic significance. Parameters that would identify patients who are at increased risk of arrhythmias and appropriate ICD interventions would be of clinical value. The aim of the study is to evaluate the usefulness of non-invasive programmed stimulation (NIPS) in determining the likelihood of life-threatening arrhythmic events in patients with ICD.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with appropriate intervention of ICD
timeFrame: up to 1 year from date of randomization
Secondary outcomes:
measure: Number of participants with sudden cardiac (arrhythmic) death
timeFrame: up to 1 year from date of randomization
Other outcomes:
measure: Number of participants with death from cardiovascular causes
timeFrame: up to 1 year from date of randomization
measure: Number of participants with hospitalization for cardiovascular causes
timeFrame: up to 1 year from date of randomization
Locations:
city: Rzeszów
country: Poland
facility: St. Joseph's Centre
state: Subcarpathian District
Study officials:
affiliation: Postgraduate Medical School, Warsaw
name: Piotr Kułakowski, MD, PhD, FESC
role: STUDY_CHAIR
affiliation: St. Joseph's Centre, Rzeszów
name: Piotr Futyma, MD
role: PRINCIPAL_INVESTIGATOR
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