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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01906775
Other study ID # PIT in ICD patients
Secondary ID
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


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
See also
  Status Clinical Trial Phase
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Completed NCT01492764 - Ablation of Ventricular Fibrillation by Accurate Targeting of Arrhythmogenic Regions (AVATAR)
Completed NCT00853645 - Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System N/A