SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR

Sudden Cardiac Death Clinical Trial

— SIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04101253
• Other study ID #: CHPAU2019/02
• Status: Completed
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: February 14, 2023

Study information

• Verified date: April 2023
• Source: Centre Hospitalier de PAU
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: February 14, 2023
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Implantable Defibrillator
• Sudden Cardiac Death

Intervention

Procedure:
• new screening procedure with small variations in electrode positioning
Every ICD patient will undergo the standard screening process. Initial screening will be performed as usually performed by physician or Boston Scientific technical support. In case of one or more vector satisfying screening criteria, patient will be assigned in "screening success" group. In case of failure, a pre-determined electrode positioning protocol will be done with variation of para-sternal and axillary electrodes. Positioning variations will be left to the discretion of the operator cardiologist.

Locations

Country	Name	City	State
France	CHRU de BREST	Brest
France	CHU de Caen	Caen
France	CHRU de Lille	Lille
France	Hopital Saint Philivert	Lille
France	CHU de Limoges	Limoges
France	Hopitl Cardiologique Louis Pradel	Lyon
France	CHU de Nancy	Nancy
France	CHU de Nantes	Nantes
France	AP-HP Hôpital européen Georges-Pompidou	Paris
France	APHP - Pitié Salpêtrière	Paris
France	CH de Pau	Pau
France	CHU de Rennes	Rennes
France	CHRU de Strasbourg	Strasbourg
France	CHU deToulouse	Toulouse
France	Clinique Pasteur	Toulouse
France	CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de PAU

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	screening success rates	Comparison of success rates between the standard screening procedure (without repositioning the electrodes) and the proposed new procedure (small variations in electrode positioning)	one day