Ventricular Fibrillation
Conditions
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.
Interventions
DEVICEcommercially 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
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Defibrillation Threshold (DFT) of the New Shock Electrode Configuration in Joules | Acute- During the implant procedure- up to 1 hour | The primary objective of this acute feasibility study is to measure the DFT of the new shock electrode configuration with an S-ICD system. The unit of measure will be in Joules. Ventricular Fibrillation (VF) will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Ventricular Fibrillation (VF) Conversion at 40 Joules | Acute- During the implant procedure- up to 1 hour | The secondary objective is to assess the conversion success of the new electrode configuration to convert VF. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol |
Countries
Netherlands
Participant flow
Recruitment details
Subjects who were scheduled to receive an subcutaneous implantable cardioverter defibrillator (S-ICD), and fulfilled the inclusion and exclusion criteria, could be approached for enrollment and consent within 30 days of their scheduled implant.
Participants by arm
| Arm | Count |
|---|---|
| Acute Test Subjects receiving a commercial S-ICD system for per manufacturer indications and medical society guidelines | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Acute Test | — |
|---|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 17 | — |
| Left Ventricular Ejection Fraction | 40 percent STANDARD_DEVIATION 15 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Netherlands | 35 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 28 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 16 / 42 |
| serious Total, serious adverse events | 1 / 42 |
Outcome results
Primary
Defibrillation Threshold (DFT) of the New Shock Electrode Configuration in Joules
The primary objective of this acute feasibility study is to measure the DFT of the new shock electrode configuration with an S-ICD system. The unit of measure will be in Joules. Ventricular Fibrillation (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- up to 1 hour
Population: transverse testing was added in phase 2, so fewer subjects tested. Only subjects completing testing were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parallel Shock Configuration | Defibrillation Threshold (DFT) of the New Shock Electrode Configuration in Joules | 27.0 Joules | Standard Deviation 8.8 |
| Transverse Shock Configuration | Defibrillation Threshold (DFT) of the New Shock Electrode Configuration in Joules | 31.5 Joules | Standard Deviation 9.3 |
Secondary
Number of Participants With Successful Ventricular Fibrillation (VF) Conversion at 40 Joules
The secondary objective is to assess the conversion success of the new electrode configuration to convert VF. 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- up to 1 hour
Population: Transverse was added in Phase 2 so fewer subjects tested.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Parallel Shock Configuration | Number of Participants With Successful Ventricular Fibrillation (VF) Conversion at 40 Joules | 32 Participants |
| Transverse Shock Configuration | Number of Participants With Successful Ventricular Fibrillation (VF) Conversion at 40 Joules | 18 Participants |