NIPS to Identify High-risk Patients With ICD (NIPS-ICD)

October 25, 2016 updated by: Piotr Futyma, St. Joseph's Centre, Poland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Subcarpathian District
      • Rzeszów, Subcarpathian District, Poland, 35-623
        • St. Joseph's Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with appropriate intervention of ICD
Time Frame: up to 1 year from date of randomization
Appropriate intervention of ICD due to ventricular arrhythmia
up to 1 year from date of randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with sudden cardiac (arrhythmic) death
Time Frame: 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
up to 1 year from date of randomization

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

December 23, 2014

First Submitted That Met QC Criteria

February 26, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIPS-ICD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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