Sub-threshold Pacing to Prevent Pacemaker-induced Ventricular Tachycardia

NCT ID: NCT01906775

Last Updated: 2013-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-06-30

Study Completion Date

2013-05-31

Brief Summary

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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

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Conditions

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Ventricular Tachyarrhythmias ICD Shock Therapy ICD Shock Burden

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with PIT

Identification of patients with pacemaker-induced ventricular tachycardias

Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level

Intervention Type OTHER

Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level to achieve an ineffective pacing output

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Thomas Rostock

Univ.-Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Mainz, II. Medical Clinic, Dept. of Electrophysiology

Mainz, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 24654876 (View on PubMed)

Other Identifiers

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PIT in ICD patients

Identifier Type: -

Identifier Source: org_study_id

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