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Acute Feasibility Investigation of a New S-ICD Electrode (ASE)

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ClinicalTrials.gov Identifier: NCT03802110
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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

Condition or disease Intervention/treatment Phase
Ventricular Fibrillation Device: commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Feasibility Investigation of a New S-ICD Electrode Arrangement for Reduction of Defibrillation Energies
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : November 15, 2020
Estimated Study Completion Date : December 15, 2020


Arm Intervention/treatment
Experimental: Single Arm
Defibrillation threshold (DFT) testing Arm
Device: commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.
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
Other Name: The S-ICD System is a Subcutaneous (under the skin) Implantable Cardioverter Defibrillator for people who are at risk of Sudden Cardiac Arrest




Primary Outcome Measures :
  1. Measure defibrillation threshold defibrillation threshold (DFT) of the new shock electrode configuration in Joules [ Time Frame: Acute- During the implant procedure ]
    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 :
  1. Conversion succes of the new electrode configuration [ Time Frame: Acute- During the implant procedure ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Subject is scheduled to receive a de novo S-ICD system implant per labeled indication.
  2. Passing S-ICD screening ECG performed per applicable user's manual.
  3. Subject is willing and capable of providing informed consent specific to local and national laws.
  4. Subject is age 18 or above, or of legal age to give informed consentspecific to local and national law.

Key Exclusion Criteria:

  1. 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.
  2. Subject has a left ventricular ejection fraction ≤ 20% within 3 months prior to enrollment.
  3. Subject has NYHA Class IV or unstable Class III heart failure.
  4. Subject that, in the opinion of the investigator, cannot tolerate the DFT testing required by this protocol.
  5. Subject is morbidly obese, defined as BMI ≥ 35.
  6. Subject has hypertrophic cardiomyopathy.
  7. Subject has Brugada syndrome.
  8. Subject has an active infection or has been treated for infection within the past 30 days.
  9. Subject that, in the opinion of the investigator, has an increased risk of infection.
  10. Subject is currently requiring/receiving dialysis.
  11. Subject has insulin-dependent diabetes.
  12. Subject had/has any prior or planned other surgical procedure within ±30 days of enrollment.
  13. Subject that, in the opinion of the investigator, has an increased risk for thromboembolic event.
  14. Subject that, in the opinion of the investigator, has an increased risk of excessive bleeding.
  15. Subject is currently on an active heart transplant list.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802110


Contacts
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Contact: Anneleen Viville +32 24167288 Anneleen.viville@bsci.com

Locations
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Netherlands
AMC Recruiting
Amsterdam, Netherlands
Contact: Reinoud Knops, MD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Reinoud Knops AIDS Malignancy Consortium

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03802110     History of Changes
Other Study ID Numbers: C2081
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes