Implantable Defibrillator User Clinical Trial
— Surge-ICDOfficial title:
Shock Testing to Unmask RV Lead and GEnerator Malfunction in ICD Patients: the SURGE-ICD Registry
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 15, 2025 |
Est. primary completion date | June 15, 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Germany | Department of electrophysiology, Heart Center Cologne, University of Cologne | Cologne | NRW |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Köln |
Germany,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lead failure after HV shock | Any single or combination of the following observations:
HV impedance >20 Ohm Pacing impedance >2000 Ohm Pacing threshold >5V/0,4ms Pacing threshold increase by factor 2 or more Pacing exit block Sensing < 4mV Relative decrease in sensing by 50% or more Detection of lead noise or artifacts on the RV pace-sense or shock channel Any lead associated error reports by the ICD preventing delivery of the ICD shock |
3 hours within testing | |
Secondary | Changes in Device Function not leading to primary outcome | Before shock to after shock absolute and relative changes in lead-measures | 3 hours within testing | |
Secondary | Adverse events within shock testing | Any adverse events occuring during shock testing | 3 hours within testing | |
Secondary | Rhythm after synchronized shock | In the "internal cardioversion" group: success of internal shock | 3 hours within testing |
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