Status:
UNKNOWN
Shock Testing to Unmask RV Lead and GEnerator Malfunction in ICD Patients: the SURGE-ICD Registry
Lead Sponsor:
Universitätsklinikum Köln
Conditions:
Implantable Defibrillator Lead Dysfunction
Implantable Automatic Defibrillator Malfunction
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
Testing the ICD system during initial implantation was the standard of care for a long time. Since the publication of the SIMPLE trial, most centers have abandoned this practice for all uncomplicated,...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Informed, written consent
- Status post ICD implantation, including CRT-D
- Battery in EOL, ERM or ERI, ERT with indication for elective ICD generator replacement or patients presenting for electrical cardioversion for atrial arrhythmia.
Exclusion
- Age \< 18 years
- Pregnancy
- Patients under guardianship or with mental disorders/disabilities
- Recent adequate and successful ICD shock therapy (within the past 12 months)
- Patients in the cardioversion arm with low battery (\<1 year to ERI/RRT)
- Patients with intracardiac thrombus
- Participation in any other investigational study that may interfere with interpretation of the study and registry results
- Indications of an already compromised RV lead (Pacing impedance \<200 or \>2000 Ohm, Pacing threshold \>5V/0.4ms, RV Sensing \<4mV, HV impedance \>80, presence of lead noise)
- Systems with recalled leads or leads known to have an elevated failure risk: Riata™ and Riata ST™ (St. Jude Medical, St. Paul, Minnesota, USA), Sprint Fidelis™ (Medtronic, Minneapolis, Minnesota, USA)
Key Trial Info
Start Date :
March 23 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 15 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04858672
Start Date
March 23 2022
End Date
June 15 2025
Last Update
June 2 2022
Active Locations (1)
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1
Department of electrophysiology, Heart Center Cologne, University of Cologne
Cologne, North Rhine-Westphalia, Germany, 50937