Sub-threshold Pacing to Prevent Pacemaker-induced Ventricular Tachycardia

July 23, 2013 updated by: Thomas Rostock, Johannes Gutenberg University Mainz

Sub-threshold Ventricular Back-up 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

550

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

  • Germany
      • Mainz, Germany, D-55131
        • University Hospital Mainz, II. Medical Clinic, Dept. of Electrophysiology

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients having an implanted ICD for secondary prevention of ventricular tachyarrhythmias. Patients are routinely under follow-up for device interrogation in our outpatient device department.

Patients with identified pacemaker-induced ventricular tachycardia were selected and after two or more episodes of VT, the ventricular back-up pacing was reprogrammed to a sub-threshold level.

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with PIT
Identification of patients with pacemaker-induced ventricular tachycardias
Other: Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level
Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level to achieve an ineffective pacing output

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of arrhythmia / Number of arrhythmia
Time Frame: 48 months
Analysis of the number and the types of recurrent arrhythmias requiring ICD shock termination
48 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of PIT versus other VTs
Time Frame: 48 months
Measurement of the proportion of PIT versus other VTs requiering ICD shock termination
48 months

Collaborators and Investigators

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

Sponsor

Johannes Gutenberg University Mainz

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

June 1, 2003

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 20, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (Estimate)

July 24, 2013

Study Record Updates

Last Update Posted (Estimate)

July 24, 2013

Last Update Submitted That Met QC Criteria

July 23, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIT in ICD patients

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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