Clinical trial NCT04101253: SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR
Official title: SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR: OPTIMIZATION OF THE PROCEDURE BY REPOSITIONING THE ELECTRODES AND RESEARCH OF THE PREDICTIVE FACTORS OF FAILURE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sudden Cardiac Death
Implantable Defibrillator
Lead sponsor: Centre Hospitalier de PAU
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: S-ICD (subcutaneous implantable cardioverter-defibrillator) screening failure occurs in about 10% of cases. Predictors of screening failure are not yet well determined. Moreover, slight variations in electrode positioning may change vector configuration and therefore improve screening success rates

Detailed description: S-ICD (subcutaneous implantable cardioverter-defibrillator) has become the last years widespread in various pathological conditions and implantation rates are increasing each year worldwide. Previous to implantation it is mandatory to realize a screening in order to assess specific electrocardiographic vectors used to analyze cardiac rhythm. In routine practice, approximatively 10% of patients are recused for S-ICD device implantation due to failed screening 1-3. Causes are mainly abnormalities of R wave (low or high amplitude) and low R/T wave ratio. Determinants for screening failure have not yet been clearly studied. Moreover, it is a common finding in S-ICD implantation to find variations between pre-implant electrograms and electrograms recorded by the device. Variations of R wave amplitude and R/T ration are also observed with small variations of electrode positioning prior to implantation. It has been also shown that despite initial screening failure, S-ICD could be securely performed in some cases 4,5. Patients included in the study will undergo usual screening protocol. In case of failure a 2nd screening will be realize with slight electrode positioning variations compatible with S-ICD and lead placement. In case of success modality of implantation will be decided by physician.

In case of S-ICD implantation screening data will be compared to post implantation device electrograms. A 2 month follow-up will be performed with comparison of a new screening procedure with electrodes at the level of sub-cutaneous electrodes.

Eligibility criteria: Inclusion Criteria:

* The population will be composed of all patients referred for ICD method, aged over 18 years

Exclusion Criteria:

* Age \< 18 years old
* Patients who cannot freely give their consent, or patients who refuse to participate

Primary outcomes:
measure: screening success rates
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de BREST
city: Caen
country: France
facility: CHU de Caen
city: Lille
country: France
facility: CHRU de Lille
city: Lille
country: France
facility: Hopital Saint Philivert
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Hopitl Cardiologique Louis Pradel
city: Nancy
country: France
facility: CHU de Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: AP-HP Hôpital européen Georges-Pompidou
city: Paris
country: France
facility: APHP - Pitié Salpêtrière
city: Pau
country: France
facility: CH de Pau
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Toulouse
country: France
facility: CHU deToulouse
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHU de Tours
Study officials:
References: