Sub-threshold Pacing to Prevent Pacemaker-induced Ventricular Tachycardia
Sub-threshold Ventricular Back-up Pacing to Prevent Pacemaker-induced Ventricular Tachycardia
1 other identifier
observational
550
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2003
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 20, 2013
CompletedFirst Posted
Study publicly available on registry
July 24, 2013
CompletedJuly 24, 2013
July 1, 2013
9.3 years
July 20, 2013
July 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of VT requiring ICD shock
Patients were followed-up for the occurrence of ventricular tachycardia requiring ICD shock therapy
48 months follow-up
Secondary Outcomes (1)
Type of arrhythmia / Number of arrhythmia
48 months
Other Outcomes (1)
Incidence of PIT versus other VTs
48 months
Study Arms (1)
Patients with PIT
Identification of patients with pacemaker-induced ventricular tachycardias
Interventions
Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level to achieve an ineffective pacing output
Eligibility Criteria
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.
You may qualify if:
- age \> 18 years
- implanted ICD
- occurrence of pacemaker-induced VT
You may not qualify if:
- documentation of pause-related syncope
- AV block
- sick-sinus syndrome
- younger than 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Mainz, II. Medical Clinic, Dept. of Electrophysiology
Mainz, D-55131, Germany
Related Publications (1)
Theis C, Mollnau H, Sonnenschein S, Konrad T, Himmrich E, Bock K, Schulz E, Kampfner D, Gerhardt S, Quesada Ocete B, Munzel T, Rostock T. Reduction of ICD shock burden by eliminating back-up pacing induced ventricular tachyarrhythmias. J Cardiovasc Electrophysiol. 2014 Aug;25(8):889-895. doi: 10.1111/jce.12418. Epub 2014 May 2.
PMID: 24654876DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Univ.-Prof. Dr. med.
Study Record Dates
First Submitted
July 20, 2013
First Posted
July 24, 2013
Study Start
June 1, 2003
Primary Completion
September 1, 2012
Study Completion
May 1, 2013
Last Updated
July 24, 2013
Record last verified: 2013-07