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

April 7, 2023 updated by: Centre Hospitalier de PAU

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
screening success rates
Time Frame: one day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de PAU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2019

Primary Completion (Actual)

January 5, 2022

Study Completion (Actual)

February 14, 2023

Study Registration Dates

First Submitted

September 19, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 24, 2019

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 7, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHPAU2019/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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