Clinical trial NCT04206371: Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement
Official title: Longitudinal Follow-up of Patients With Defibrillator Threshold Testing During Implantable Cardioverter Defibrillator (ICD) Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implantable Cardioverter-Defibrillators
Keywords: Defibrillation threshold testing
Defibrillation lead
Defibrillator replacement
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Detailed 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.

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)

Primary outcomes:
measure: Rate of defibrillator electrical integrity dysfunction during generator replacement.
timeFrame: 4 hours
Secondary outcomes:
measure: Rate of lead malfunction
timeFrame: 12 months
Other outcomes:
Locations:
city: Chambray-lès-Tours
country: France
facility: Hôpital Trousseau
state: Centre-Val De Loire
city: Vandœuvre-lès-Nancy
country: France
facility: Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu-CHU de Nancy-Hôpitaux de Brabois
state: Grand Est
city: Neuilly-sur-Seine
country: France
facility: CMC Ambroise Paré
state: Ile-de-France
city: Caen
country: France
facility: CHU de Caen
state: Normandie
city: Toulouse
country: France
facility: CHU de Toulouse-Hôpital Rangueil
state: Occitanie
city: Nantes,
country: France
facility: Hôpital Privé du Confluent
state: Pays De La Loire
city: Avignon
country: France
facility: Centre Hospitalier Henri Duffaut
state: Provence-Alpes-Côte d'Azur
Study officials:
References: