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SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR (SIS)

Primary Purpose

Sudden Cardiac Death, Implantable Defibrillator

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
new screening procedure with small variations in electrode positioning
Sponsored by
Centre Hospitalier de PAU
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sudden Cardiac Death

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de BREST
  • CHU de Caen
  • CHRU de Lille
  • Hopital Saint Philivert
  • CHU de Limoges
  • Hopitl Cardiologique Louis Pradel
  • CHU de Nancy
  • CHU de Nantes
  • AP-HP Hôpital européen Georges-Pompidou
  • APHP - Pitié Salpêtrière
  • CH de Pau
  • CHU de Rennes
  • CHRU de Strasbourg
  • CHU deToulouse
  • Clinique Pasteur
  • CHU de Tours

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
September 19, 2019
Last Updated
April 7, 2023
Sponsor
Centre Hospitalier de PAU
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1. Study Identification

Unique Protocol Identification Number
NCT04101253
Brief Title
SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
January 5, 2022 (Actual)
Study Completion Date
February 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de PAU

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Cardiac Death, Implantable Defibrillator

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
new screening procedure with small variations in electrode positioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
screening success rates
Description
Comparison of success rates between the standard screening procedure (without repositioning the electrodes) and the proposed new procedure (small variations in electrode positioning)
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHRU de BREST
City
Brest
Country
France
Facility Name
CHU de Caen
City
Caen
Country
France
Facility Name
CHRU de Lille
City
Lille
Country
France
Facility Name
Hopital Saint Philivert
City
Lille
Country
France
Facility Name
CHU de Limoges
City
Limoges
Country
France
Facility Name
Hopitl Cardiologique Louis Pradel
City
Lyon
Country
France
Facility Name
CHU de Nancy
City
Nancy
Country
France
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Name
AP-HP Hôpital européen Georges-Pompidou
City
Paris
Country
France
Facility Name
APHP - Pitié Salpêtrière
City
Paris
Country
France
Facility Name
CH de Pau
City
Pau
Country
France
Facility Name
CHU de Rennes
City
Rennes
Country
France
Facility Name
CHRU de Strasbourg
City
Strasbourg
Country
France
Facility Name
CHU deToulouse
City
Toulouse
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Facility Name
CHU de Tours
City
Tours
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATOR

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