Sub-threshold Pacing to Prevent Pacemaker-induced Ventricular Tachycardia

Ventricular Tachyarrhythmias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906775
• Other study ID #: PIT in ICD patients
• Status: Completed
• Phase: N/A
• First received: July 20, 2013
• Last updated: July 23, 2013
• Start date: June 2003
• Est. completion date: May 2013

Study information

• Verified date: July 2013
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: May 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• ICD Shock Burden
• ICD Shock Therapy
• Shock
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachyarrhythmias

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Mainz, II. Medical Clinic, Dept. of Electrophysiology	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of PIT versus other VTs	Measurement of the proportion of PIT versus other VTs requiering ICD shock termination	48 months	No
Primary	Occurrence of VT requiring ICD shock	Patients were followed-up for the occurrence of ventricular tachycardia requiring ICD shock therapy	48 months follow-up	No
Secondary	Type of arrhythmia / Number of arrhythmia	Analysis of the number and the types of recurrent arrhythmias requiring ICD shock termination	48 months	No