Testing ICD leads for hidden failures in patients needing generator replacement
Shock Testing to Unmask RV Lead and GEnerator Malfunction in ICD Patients: the SURGE-ICD Registry
This study is testing if a special shock can uncover hidden problems with the wires in heart devices for patients who need their battery replaced, to make sure they are still safe and effective.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Köln Academic / other |
| Locations | 1 site (Cologne, NRW) |
| Trial ID | NCT04858672 on ClinicalTrials.gov |
What this trial studies
This registry aims to investigate the prevalence of silent lead failures in patients with implantable cardioverter defibrillators (ICDs) who are undergoing generator replacement or electrical cardioversion. The study will involve administering a high-energy shock to provoke any undetected lead malfunctions, which may not be revealed through standard testing methods. By assessing the functionality of ICD leads, the study seeks to ensure that patients receive effective life-saving therapy. The findings could provide critical insights into the safety of current practices regarding ICD lead testing.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have undergone ICD implantation and are in need of generator replacement or electrical cardioversion.
Not a fit: Patients under 18, pregnant individuals, or those with specific lead issues or recent successful ICD shocks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance patient safety by identifying malfunctioning ICD leads, ensuring that patients receive reliable defibrillation when needed.
How similar studies have performed: While this approach is based on previous findings regarding silent lead failures, the specific methodology of this registry has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Cologne, NRW
- Department of electrophysiology, Heart Center Cologne, University of Cologne — Cologne, Nrw, Germany (Recruiting)
Study contacts
- Principal investigator: Daniel Steven, Prof. — University of Cologne, Heart Center, Dept. of Electrophysiology
- Study coordinator: Jonas Wörmann, MD
- Email: jonas.woermann@uk-koeln.de
- Phone: +4917699992357
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.