The primary objective of this acute feasibility study is to assess the defibrillation threshold (DFT) when adding a second left parasternal electrode to an S-ICD system.The secondary objective is to assess the efficacy of the 2-electrode…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Defibrillation Threshold (DFT) of the two-electrode shock configuration
(Parallel and 90º)
Secondary outcome
* VF conversion success for the two-electrode shock configuration (Parallel and
90º)
* Shock impedance of both the one- and two-electrode shock configurations
(Parallel and 90º)
Background summary
The current S-ICD system pulse generator (PG) is 59 cc in size and delivers a
maximum energy shock of 80 J. Any significant reduction in PG size would
require a reduction in the maximum energy output. Reducing the defibrillation
energy requirement would increase the percentage of S-ICD patients that could
receive a smaller PG.
Computer modeling of the electrical fields in a realistic human torso showed
that a wider parasternal electrode, two parallel standard S-ICD electrodes, or
two S-ICD electrodes inserted at a 90º angle reduced shock impedance, improved
current delivery and reduced defibrillation energy. Swine defibrillation
studies of the subcutaneous systems with one vs. two left parasternal
electrodes showed smaller and less consistent reduction in shock impedance and
delivered energy than the computer models. However, swine have anatomy and
electrophysiologic properties that are substantially different than humans that
affect defibrillation efficiency.
Thus, an acute human study with two left parasternal electrodes is necessary to
determine the feasibility of improving the defibrillation efficacy using the
new electrode configuration.
Study objective
The primary objective of this acute feasibility study is to assess the
defibrillation threshold (DFT) when adding a second left parasternal electrode
to an S-ICD system.
The secondary objective is to assess the efficacy of the 2-electrode
configuration (Parallel and 90º) to convert VF.
The tertiary objective is to assess factors that influence the DFT when adding
the second electrode (eg spacing and orientation or angle between electrodes).
Study design
This is a prospective, multi-site, single-arm, acute feasibility study.
Intervention
NA
Study burden and risks
While the risks of VF conversion testing are not zero, the risks in a carefully
controlled clinical trial with experienced investigators are very low. Many
such studies have been performed previously that led to many important
developments in ICD and S-ICD therapy that have benefited hundreds of thousands
of recipients. Improvements to S-ICD therapy simply cannot be made without
studies of this type.
The risk to benefit ratio for this study is reasonable because the subject is
already undergoing an S-ICD implant that includes sedation and/or anesthesia,
insertion of a subcutaneous electrode and VF conversion testing. Since the
standard implant and VF conversion test will be done prior to investigational
procedures, it provides a high degree of assurance that the VF conversion
testing is well tolerated. The protocol includes criteria to exclude subjects
from the investigational testing should the initial standard of care VF
conversion test suggest that the subject may be at higher risk for adverse
events.
Individual subjects may not receive direct benefit from participation in this
study.
The study may have a significant benefit to future S-ICD recipients if the
results of this study are favorable and allow the development of new S-ICD
systems that reduce defibrillation energies with significantly smaller pulse
generators. Thus, a patient participating in this study may receive an
indirect benefit at a later date * for example at the time of pulse generator
replacement.
Lambroekstraat (Green Square) 5D
Diegem 1831
BE
Lambroekstraat (Green Square) 5D
Diegem 1831
BE
Listed location countries
Age
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 expected to be implanted with a left parasternal S-ICD electrode.
4. Subject*s planned S-ICD implant procedure will include at least one VF
conversion testing at 65 J.
5. Subject is willing and capable of providing informed consent specific to
local and national laws.
6. Subject is age 18 or above, or of legal age to give informed consent
specific to local and national law.
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 less than or equal to 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 that, in the opinion of the investigator, is at increased risk for
VF conversion failure.
6. Subject is morbidly obese, defined as BMI greater than or equal to 35.
7. Subject has an active infection or has been treated for infection within the
past 30 days.
8. Subject that, in the opinion of the investigator, has an increased risk of
infection.
9. Subject is currently requiring/receiving dialysis.
10. Subject has insulin-dependent diabetes.
11. Subject had/has any prior or planned other surgical procedure within ±30
days of enrollment.
12. Subject is receiving immunosupressive therapy or has a condition that
compromises their immune system.
13. Subject had episodes of atrial fibrillation or atrial flutter within the 4
week period prior to enrollment or during the period of time between enrollment
and the start of implant procedure.
14. Subject that, in the opinion of the investigator, has an increased risk for
thromboembolic event.
15. Subject that, in the opinion of the investigator, has an increased risk of
excessive bleeding.
16. Subject is currently on an active heart transplant list.
17. Subjects with documented life expectancy of less than 12 months.
18. Subject has any other electrically active implanted device that cannot be
temporarily deactivated during the implant (includes components or accessories
present such as pulse generators, non-capped leads or leads with breached
insulation, implantable cardiac monitors, implantable stimulators).
19. Subject is enrolled in a concurrent study, with the exception of local
mandatory governmental registries and observational studies/registries, without
prior written approval from Boston Scientific.
20. Women of childbearing potential who are or might be pregnant at the time of
the S-ICD implant procedure.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62605.018.17 |