Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement

Implantable Cardioverter-Defibrillators Clinical Trial

— T-DEF  

Official title:

Longitudinal Follow-up of Patients With Defibrillator Threshold Testing During Implantable Cardioverter Defibrillator (ICD) Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206371
• Other study ID #: 2019/08
• Status: Completed
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: June 27, 2023

Study information

• Verified date: September 2023
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement.

Description:

Implantable cardioverter defibrillators (ICD) are strongly recommended in patients with left ventricular systolic function ≤35% or selected patients with channelopathies and cardiomyopathies.

Defibrillation threshold testing (DFT) defines the minimal energy required to successfully terminate a ventricular arrhythmia by an ICD. It remains the gold standard to evaluate the electrical integrity of the device. However inherent complications of this procedure have been registered, such as refractory ventricular fibrillation, and the need for this practice during implant and/or replacement of ICD has recently been questioned.

If several studies have led to abandonment of the DFT during initial ICD implant, its interest during replacement is still controversial. Indeed, the leads essential for the device electrical integrity are older, more fragile, and the ICD replacement may damage it.

Device replacement is indicated when battery reaches the point of Elective Replacement Interval (ERI).

Patients over 18 years old with indication for replacement of defibrillator will be included. Patient's informations (comorbidities, medical history and events during hospitalization or follow-up) and device characteristics will be collected. Procedure will be realized under local or general anesthesia and prophylactic antibiotic will be administrated. Leads will be tested before and after the implantation of the new device. After connexion of the new implanted device to the leads a DFT will be performed. Protocol of DFT will be decided by the physician who will chose between induction of ventricular fibrillation or R-wave synchronized shock. Patients will be followed for 6 and 12 months from the date of defibrillator replacement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: June 27, 2023
• Est. primary completion date: January 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Implantable Cardioverter-Defibrillators

Intervention

Diagnostic Test:
• Defibrillator threshold testing
Under general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock

Locations

Country	Name	City	State
France	Centre Hospitalier Henri Duffaut	Avignon	Provence-Alpes-Côte d'Azur
France	CHU de Caen	Caen	Normandie
France	Hôpital Trousseau	Chambray-lès-Tours	Centre-Val De Loire
France	Hôpital Privé du Confluent	Nantes,	Pays De La Loire
France	CMC Ambroise Paré	Neuilly-sur-Seine	Ile-de-France
France	CHU de Toulouse-Hôpital Rangueil	Toulouse	Occitanie
France	Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu-CHU de Nancy-Hôpitaux de Brabois	Vandœuvre-lès-Nancy	Grand Est

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of defibrillator electrical integrity dysfunction during generator replacement.	Abnormal shock impedance value.	4 hours
Secondary	Rate of lead malfunction	abnormal impedance value	12 months