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Sub-threshold Pacing to Prevent Pacemaker-induced Ventricular Tachycardia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01906775
First Posted: July 24, 2013
Last Update Posted: July 24, 2013
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.
Information provided by (Responsible Party):
Thomas Rostock, Johannes Gutenberg University Mainz
  Purpose
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.

Condition Intervention
Ventricular Tachyarrhythmias ICD Shock Therapy ICD Shock Burden Other: Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sub-threshold Ventricular Back-up Pacing to Prevent Pacemaker-induced Ventricular Tachycardia

Resource links provided by NLM:


Further study details as provided by Thomas Rostock, Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • Incidence of PIT versus other VTs [ Time Frame: 48 months ]
    Measurement of the proportion of PIT versus other VTs requiering ICD shock termination


Enrollment: 550
Study Start Date: June 2003
Study Completion Date: May 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
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): NCT01906775


Locations
Germany
University Hospital Mainz, II. Medical Clinic, Dept. of Electrophysiology
Mainz, Germany, D-55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Rostock, Univ.-Prof. Dr. med., Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01906775     History of Changes
Other Study ID Numbers: PIT in ICD patients
First Submitted: July 20, 2013
First Posted: July 24, 2013
Last Update Posted: July 24, 2013
Last Verified: July 2013

Keywords provided by Thomas Rostock, Johannes Gutenberg University Mainz:
ICD
ventricular tachyarrhythmia
shock
sub-threshold pacing

Additional relevant MeSH terms:
Shock
Tachycardia
Tachycardia, Ventricular
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases