NIPS to Identify High-risk Patients With ICD

NCT02373306 | Completed

• 1 other identifier: NIPS-ICD
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Arrhythmia

Keywords

Risk stratification; ICD intervention; occurrence during one-year follow-up after NIPS

Outcome Measures

Primary Outcomes (1)

• Number of participants with appropriate intervention of ICD

  Appropriate intervention of ICD due to ventricular arrhythmia

  up to 1 year from date of randomization

Secondary Outcomes (1)

• Number of participants with sudden cardiac (arrhythmic) death

  up to 1 year from date of randomization

Other Outcomes (2)

• Number of participants with death from cardiovascular causes

  up to 1 year from date of randomization

• Number of participants with hospitalization for cardiovascular causes

  up to 1 year from date of randomization

Study Arms (2)

NIPS-sensitive group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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

Interventions

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

NIPS-sensitive group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Centre, Poland: lead

Study Sites (1)

St. Joseph's Centre

Rzeszów, Subcarpathian District, 35-623, Poland

Location

Related Publications (30)

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  PMID: 26818636 DERIVED

MeSH Terms

Interventions

Sulfamethazine

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Piotr Kułakowski, MD, PhD, FESC

  Postgraduate Medical School, Warsaw

  STUDY CHAIR

• Piotr Futyma, MD

  St. Joseph's Centre, Rzeszów

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: February 27, 2015
• Study Start: November 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

PL (1)