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Shock Testing to Unmask RV Lead and GEnerator Malfunction in ICD Patients: the SURGE-ICD Registry

NCT04858672 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2022-06-02

No results posted yet for this study

Summary

Shock testing during ICD generator replacement has been omitted by many centers. A previous study revealed lead failures in internally cardioverted patients with previously normal HV-lead values. The real prevalence of unrecognized "silent" lead failure in ICD patients remains unknown.

As a consequence, patients may be equipped with an ICD which is unable to provide life-saving shocks. The proposed registry aims to include patients presenting for ICD generator replacement or electrical cardioversion of atrial arrhythmia. The protocol mandates either a commanded synchronized high energy shock prior to generator replacement or internal cardioversion of atrial arrhythmia to provoke the unmasking of silent lead failure.

Conditions

  • Implantable Defibrillator Lead Dysfunction
  • Implantable Automatic Defibrillator Malfunction
  • Implantable Defibrillator User

Sponsors & Collaborators

  • Universitätsklinikum Köln

    lead OTHER

Principal Investigators

  • Daniel Steven, Prof. · University of Cologne, Heart Center, Dept. of Electrophysiology

  • Jakob Lüker, Dr. · University of Cologne, Heart Center, Dept. of Electrophysiology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-23
Primary Completion
2025-06-15
Completion
2025-06-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04858672 on ClinicalTrials.gov