NIPS-ICD: NIPS to Identify High-risk Patients With ICD

Sponsor

St. Joseph's Centre, Poland (Other)

Overall Status

Completed

CT.gov ID

NCT02373306

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Arrhythmia	Procedure: Sustained or hemodynamically unstable arrhythmia induction during non-invasive programmed stimulation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NIPS-sensitive group Patients who had sustained or hemodynamically unstable arrhythmia induction during non-invasive programmed stimulation.	Procedure: Sustained or hemodynamically unstable arrhythmia induction during non-invasive programmed stimulation
No Intervention: Control group Patients who had no sustained or hemodynamically unstable arrhythmias induction during non-invasive programmed stimulation.

Arm

Intervention/Treatment

Active Comparator: NIPS-sensitive group

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

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

No Intervention: Control group

Patients who had no sustained or hemodynamically unstable arrhythmias induction during non-invasive programmed stimulation.

Outcome Measures

Primary Outcome Measures

Number of participants with appropriate intervention of ICD [up to 1 year from date of randomization]
Appropriate intervention of ICD due to ventricular arrhythmia

Secondary Outcome Measures

Number of participants with sudden cardiac (arrhythmic) death [up to 1 year from date of randomization]
Death due to sustained VT/VF, or in the absence of available documentation - death which occurred within one hour of the onset of symptoms

Other Outcome Measures

Number of participants with death from cardiovascular causes [up to 1 year from date of randomization]
Death due to VF, extensive myocardial infarction, electromechanical dissociation, asystole, or end-stage heart failure.
Number of participants with hospitalization for cardiovascular causes [up to 1 year from date of randomization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Centre	Rzeszów	Subcarpathian District	Poland	35-623

Sponsors and Collaborators

St. Joseph's Centre, Poland

Investigators

Study Chair: Piotr Kułakowski, MD, PhD, FESC, Postgraduate Medical School, Warsaw
Principal Investigator: Piotr Futyma, MD, St. Joseph's Centre, Rzeszów