Clinical trial NCT03802110: Acute Feasibility Investigation of a New S-ICD Electrode
Official title: Acute Feasibility Investigation of a New S-ICD Electrode Arrangement for Reduction of Defibrillation Energies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-01-14
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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 generator (PG). A system that defibrillates with lower energy could significantly reduce PG size. Computer modeling and animal studies suggest a 2nd shock coil either parallel (P) to LPC or transverse (T) from xiphoid to PG pocket would significantly reduce shock impedance and defibrillation threshold (DFT).

Objective: Acutely test defibrillation efficacy of P and T configurations in patients receiving an S-ICD.

Methods: Testing was performed in patients receiving a conventional S-ICD system (C) for standard indications. Patients at risk for conversion failure, stroke or infection were excluded. A 65 J success with the conventional S-ICD was required prior to investigational testing. A second electrode was temporarily inserted from the xiphoid incision using the same introducer and sheath tools and connected to the PG with an investigational Y-adapter (Model 3598, Boston Scientific). Phase 1 (n=11) tested only P at a starting energy of 50 J with subsequent tests at 65 or 30 J then 40 or 20 J depending upon outcome. Phase 2 (n=21) tested both P and T in random order, starting at 30 J then either 40 or 20 J.

Eligibility 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 an active infection or has been treated for infection within the past 30 days.
7. Subject that, in the opinion of the investigator, has an increased risk of infection.
8. Subject is currently requiring/receiving dialysis.
9. Subject has insulin-dependent diabetes.
10. Subject had/has any prior or planned other surgical procedure within ±30 days of enrollment.
11. Subject that, in the opinion of the investigator, has an increased risk for thromboembolic event.
12. Subject that, in the opinion of the investigator, has an increased risk of excessive bleeding.
13. Subject is currently on an active heart transplant list.

Primary outcomes:
measure: Defibrillation Threshold (DFT) of the New Shock Electrode Configuration in Joules
timeFrame: Acute- During the implant procedure- up to 1 hour
Secondary outcomes:
measure: Number of Participants With Successful Ventricular Fibrillation (VF) Conversion at 40 Joules
timeFrame: Acute- During the implant procedure- up to 1 hour
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC - University Medical Center Rotterdam
city: Zwolle
country: Netherlands
facility: Isala Klinieken
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Reinoud Knops
role: PRINCIPAL_INVESTIGATOR
References: