Back to resultsAcute Feasibility Investigation of a New S-ICD Electrode (ASE)
Primary Purpose
Ventricular Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.
Sponsored by
About this trial
This is an interventional device feasibility trial for Ventricular Fibrillation
Eligibility Criteria
Key Inclusion Criteria:
- Subject is scheduled to receive a de novo S-ICD system implant per labeled indication.
- Passing S-ICD screening ECG performed per applicable user's manual.
- Subject is willing and capable of providing informed consent specific to local and national laws.
- Subject is age 18 or above, or of legal age to give informed consentspecific to local and national law.
Key Exclusion Criteria:
- Subject has an unusual chest anatomy (eg. pectus excavatum and pectus carinatum) that might impede the ability to temporarily insert a second S-ICD electrode.
- Subject has a left ventricular ejection fraction ≤ 20% within 3 months prior to enrollment.
- Subject has NYHA Class IV or unstable Class III heart failure.
- Subject that, in the opinion of the investigator, cannot tolerate the DFT testing required by this protocol.
- Subject is morbidly obese, defined as BMI ≥ 35.
- Subject has an active infection or has been treated for infection within the past 30 days.
- Subject that, in the opinion of the investigator, has an increased risk of infection.
- Subject is currently requiring/receiving dialysis.
- Subject has insulin-dependent diabetes.
- Subject had/has any prior or planned other surgical procedure within ±30 days of enrollment.
- Subject that, in the opinion of the investigator, has an increased risk for thromboembolic event.
- Subject that, in the opinion of the investigator, has an increased risk of excessive bleeding.
- Subject is currently on an active heart transplant list.
Sites / Locations
- Academisch Medisch Centrum
- St. Antonius Ziekenhuis
- Erasmus MC - University Medical Center Rotterdam
- Isala Klinieken
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Defibrillation threshold (DFT) testing Arm
Outcomes
Primary Outcome Measures
Measure defibrillation threshold defibrillation threshold (DFT) of the new shock electrode configuration in Joules
The primary objective of this acute feasibility study is to measure the defibrillation threshold (DFT) of the new shock electrode configuration with an S-ICD system.The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol
Secondary Outcome Measures
Conversion succes of the new electrode configuration
The secondary objective is to assess the conversion success of the new electrode configuration to convert VF. The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol
Full Information
NCT ID
NCT03802110
First Posted
November 8, 2018
Last Updated
April 25, 2022
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03802110
Brief Title
Acute Feasibility Investigation of a New S-ICD Electrode
Acronym
ASE
Official Title
Acute Feasibility Investigation of a New S-ICD Electrode Arrangement for Reduction of Defibrillation Energies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an early-stage feasibility study. This study seeks to characterize the performance of the new electrode shock configuration with the S-ICD
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Fibrillation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Defibrillation threshold (DFT) testing Arm
Intervention Type
Device
Intervention Name(s)
commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.
Other Intervention Name(s)
The S-ICD System is a Subcutaneous (under the skin) Implantable Cardioverter Defibrillator for people who are at risk of Sudden Cardiac Arrest
Intervention Description
The S-ICD System is a Subcutaneous (under the skin) Implantable Cardioverter Defibrillator for people who are at risk of Sudden Cardiac Arrest. A new electrode configuration will be tested for Defibrillation testing ( DFT). The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol
Primary Outcome Measure Information:
Title
Measure defibrillation threshold defibrillation threshold (DFT) of the new shock electrode configuration in Joules
Description
The primary objective of this acute feasibility study is to measure the defibrillation threshold (DFT) of the new shock electrode configuration with an S-ICD system.The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol
Time Frame
Acute- During the implant procedure
Secondary Outcome Measure Information:
Title
Conversion succes of the new electrode configuration
Description
The secondary objective is to assess the conversion success of the new electrode configuration to convert VF. The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol
Time Frame
Acute- During the implant procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Subject is scheduled to receive a de novo S-ICD system implant per labeled indication.
Passing S-ICD screening ECG performed per applicable user's manual.
Subject is willing and capable of providing informed consent specific to local and national laws.
Subject is age 18 or above, or of legal age to give informed consentspecific to local and national law.
Key Exclusion Criteria:
Subject has an unusual chest anatomy (eg. pectus excavatum and pectus carinatum) that might impede the ability to temporarily insert a second S-ICD electrode.
Subject has a left ventricular ejection fraction ≤ 20% within 3 months prior to enrollment.
Subject has NYHA Class IV or unstable Class III heart failure.
Subject that, in the opinion of the investigator, cannot tolerate the DFT testing required by this protocol.
Subject is morbidly obese, defined as BMI ≥ 35.
Subject has an active infection or has been treated for infection within the past 30 days.
Subject that, in the opinion of the investigator, has an increased risk of infection.
Subject is currently requiring/receiving dialysis.
Subject has insulin-dependent diabetes.
Subject had/has any prior or planned other surgical procedure within ±30 days of enrollment.
Subject that, in the opinion of the investigator, has an increased risk for thromboembolic event.
Subject that, in the opinion of the investigator, has an increased risk of excessive bleeding.
Subject is currently on an active heart transplant list.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinoud Knops
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academisch Medisch Centrum
City
Amsterdam
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Erasmus MC - University Medical Center Rotterdam
City
Rotterdam
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acute Feasibility Investigation of a New S-ICD Electrode
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