Status:
COMPLETED
Acute Feasibility Investigation of a New S-ICD Electrode
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Ventricular Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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
Detailed Description
Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD, EMBLEM®, Boston Scientific Corp) delivers 80 J shocks from an 8 cm left-parasternal coil (LPC) to a 59 cc left lateral pulse...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03802110
Start Date
November 29 2018
End Date
April 1 2022
Last Update
May 9 2024
Active Locations (4)
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1
Academisch Medisch Centrum
Amsterdam, Netherlands
2
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
3
Erasmus MC - University Medical Center Rotterdam
Rotterdam, Netherlands
4
Isala Klinieken
Zwolle, Netherlands