N/A
N=143
Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement
Implantable Cardioverter-Defibrillators
Bottom Line
View on ClinicalTrials.gov: NCT04206371 ↗Enrolled (actual)
143
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement. — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Defibrillator threshold testing (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CMC Ambroise Paré
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement. |
1 | — |
| SECONDARY Rate of Lead Malfunction |
3 | — |
Summary
This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement.
Eligibility Criteria
Inclusion Criteria
- Patients with an ICD (VR or DR) or CRT-D undergoing generator replacement.
- Consent for participation
- Affiliation to the French social security system
Exclusion Criteria
- Atrial Fibrillation without effective anti-coagulation treatments.
- Severe Aortic valve stenosis
- Stroke occurred in the previous month
- Hemodynamic instability contraindicating the high energy shock
- Contraindication for anesthesia
- Pregnant or breastfeeding women
- Communication difficulties or neuropsychiatric disorder
- Patients under protection of the adults (guardianship, curators or safeguard of justice)
Data sourced from ClinicalTrials.gov (NCT04206371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.