Sub-threshold Pacing to Prevent Pacemaker-induced Ventricular Tachycardia

Completed

• Conditions: Ventricular Tachyarrhythmias; ICD Shock Therapy; ICD Shock Burden
• Interventions: Other: Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level

• Registration Number: NCT01906775
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2012-09
• Study Completion: 2013-05
• Status Verified: 2013-07
• Study First Submitted: 2013-07-20
• Study First Submitted QC: 2013-07-23
• Last Update Submitted: 2013-07-23
• Study First Posted: 2013-07-24
• Last Update Posted: 2013-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PIT	Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level	Identification of patients with pacemaker-induced ventricular tachycardias

Primary Outcome Measures

Name	Time	Method
Occurrence of VT requiring ICD shock	48 months follow-up	Patients were followed-up for the occurrence of ventricular tachycardia requiring ICD shock therapy

Secondary Outcome Measures

Name	Time	Method
Type of arrhythmia / Number of arrhythmia	48 months	Analysis of the number and the types of recurrent arrhythmias requiring ICD shock termination

Trial Locations

Locations (1)

University Hospital Mainz, II. Medical Clinic, Dept. of Electrophysiology; 🇩🇪 Mainz, Germany