Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tachycardia
- Sponsor
- Abbott Medical Devices
- Enrollment
- 735
- Locations
- 23
- Primary Endpoint
- Inappropriate ICD shocks
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this clinical investigation is the continued assessment of the decision accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of subjects with primary and secondary prevention of sudden cardiac death.
Detailed Description
With Ellipse™ and Fortify Assura™ ICD family, St. Jude Medical introduced enhanced device algorithms that may be helpful to further improve SVT discrimination success: SecureSense™, Far field morphology, Chamber Onset. These algorithms in combination with a tailored device setting (primary or secondary prevention) will be prospectively investigated within this trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ischemic or nonischemic cardiomyopathy
- •Primary prevention or secondary prevention of Sudden cardiac death (SCD)
- •Indication for ICD/CRT-D new implantation per current guidelines (1, 2, 3-chamber)
- •The patient is ≥ 18 years of age
- •The patient is able to understand the patient information and is capable to provide informed consent.
- •The patient has provided written informed consent prior to any investigational related procedure
Exclusion Criteria
- •Previously implanted ICD/CRT-D
- •Hypertrophic (with or without obstructive) cardiomyopathy
- •Ion channel disorders (Long/Short-QT, Brugada syndrome etc...)
- •New York Heart Association (NYHA) Class IV
- •Recent cardiac decompensation (within previous 3 months)
- •The patient is unable to comply with the follow up schedule.
- •The patient is participating in another investigational device or drug investigation.
- •The patient is pregnant or is planning to become pregnant during the duration of the investigation
Outcomes
Primary Outcomes
Inappropriate ICD shocks
Time Frame: 12 months
Freedom from inappropriate automatically delivered ICD-shocks within 12 months Follow-Up (FU) period after ICD/CRT-D implantation
Secondary Outcomes
- Cardiac deaths(12 months)
- ICD/CRT-D related SAE(12 months)
- ICD shocks for any reason(12 months)
- Inappropriate ICD therapies(12 months)
- Untreated VT/VF(12 months)
- Specificity(12 months)
- Sensitivity(12 months)
- Accuracy of ICD therapy decision(12 months)