Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement
T-DEF
Longitudinal Follow-up of Patients With Defibrillator Threshold Testing During Implantable Cardioverter Defibrillator (ICD) Replacement
1 other identifier
interventional
143
1 country
7
Brief Summary
This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2019
CompletedFirst Posted
Study publicly available on registry
December 20, 2019
CompletedStudy Start
First participant enrolled
February 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2023
CompletedSeptember 8, 2023
September 1, 2023
2 years
December 18, 2019
September 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of defibrillator electrical integrity dysfunction during generator replacement.
Abnormal shock impedance value.
4 hours
Secondary Outcomes (1)
Rate of lead malfunction
12 months
Study Arms (1)
Defibrillation testing during ICD replacment
OTHERInterventions
Under general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock
Eligibility Criteria
You may qualify if:
- Patients with an ICD (VR or DR) or CRT-D undergoing generator replacement.
- Consent for participation
- Affiliation to the French social security system
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Hôpital Trousseau
Chambray-lès-Tours, Centre-Val de Loire, 37170, France
Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu-CHU de Nancy-Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Grand Est, 54500, France
CHU de Caen
Caen, Normandy, 14000, France
CHU de Toulouse-Hôpital Rangueil
Toulouse, Occitanie, 31400, France
Hôpital Privé du Confluent
Nantes, Pays de la Loire Region, 44277, France
Centre Hospitalier Henri Duffaut
Avignon, Provence-Alpes-Côte d'Azur Region, 84902, France
CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, 92200, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2019
First Posted
December 20, 2019
Study Start
February 3, 2020
Primary Completion
January 19, 2022
Study Completion
June 27, 2023
Last Updated
September 8, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share