Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373306
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Piotr Futyma, St. Joseph's Centre, Poland

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 Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.

  2. Number of participants with hospitalization for cardiovascular causes [ Time Frame: up to 1 year from date of randomization ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373306


Locations
Layout table for location information
Poland
St. Joseph's Centre
Rzeszów, Subcarpathian District, Poland, 35-623
Sponsors and Collaborators
St. Joseph's Centre, Poland
Investigators
Layout table for investigator information
Study Chair: Piotr Kułakowski, MD, PhD, FESC Postgraduate Medical School, Warsaw
Principal Investigator: Piotr Futyma, MD St. Joseph's Centre, Rzeszów

Publications:
Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL, Smith SC Jr, Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Europace. 2006 Sep;8(9):746-837. Epub 2006 Aug 25.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Piotr Futyma, MD, St. Joseph's Centre, Poland
ClinicalTrials.gov Identifier: NCT02373306     History of Changes
Other Study ID Numbers: NIPS-ICD
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Keywords provided by Piotr Futyma, St. Joseph's Centre, Poland:
Risk stratification
ICD intervention
occurrence during one-year follow-up after NIPS