Skip to main content
OpenTrials
Completed

NCT Number: NCT01906775

Sub-threshold Pacing to Prevent Pacemaker-induced Ventricular Tachycardia

Implantable cardioverter defibrillators (ICD) may have the capacity to provoke or worsen ventricular tachyarrhythmias (VT). It has been reported that ICD shocks by itself can increase mortality. This study aimed to determine the role of back-up pacing-induced VT (PIT) to the overall ICD shock burden by avoiding pause-related ventricular back-up pacing by programming the pacing output to a sub-threshold level for ineffective pacing.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ventricular Tachyarrhythmias Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases ICD Shock Burden ICD Shock Therapy Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Mainz, II. Medical Clinic, Dept. of Electrophysiology

Mainz, D-55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years
  • implanted ICD
  • occurrence of pacemaker-induced VT

Exclusion criteria

  • documentation of pause-related syncope
  • AV block
  • sick-sinus syndrome
  • younger than 18 years

Treatment and study plan

Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level

Other

Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level to achieve an ineffective pacing output

Primary outcomes

  1. Occurrence of VT requiring ICD shock

    Time frame: 48 months follow-up

    Patients were followed-up for the occurrence of ventricular tachycardia requiring ICD shock therapy

Secondary outcomes

  1. Type of arrhythmia / Number of arrhythmia

    Time frame: 48 months

    Analysis of the number and the types of recurrent arrhythmias requiring ICD shock termination

Other outcomes

  1. Incidence of PIT versus other VTs

    Time frame: 48 months

    Measurement of the proportion of PIT versus other VTs requiering ICD shock termination

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

Sub-threshold Ventricular Back-up Pacing to Prevent Pacemaker-induced Ventricular Tachycardia

Important dates

Study start
2003
Primary completion
2012
Study completion
2013
First posted
Jul 24, 2013
Registry last updated
Jul 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.