NL-OMON55513
Completed
Not Applicable
Acute Feasibility Investigation of a New S-ICD Electrode Arrangement for Reduction of Defibrillation Energies - ASE Study protocol C2081
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- cardiovascular disease
- Sponsor
- Boston Scientific
- Enrollment
- 42
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject is scheduled to receive a de novo S\-ICD system implant per labeled
- •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
- •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\.
Outcomes
Primary Outcomes
Not specified
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