Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators (ReduceIT)

Abbott

Status: Completed

Conditions: Tachycardia

Treatments: Device: ICD with enhanced SVT discriminators

Study type: Interventional

Funder types: Industry

Identifiers

NCT01963286

CR-12-092-GE-HV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 735 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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735 participants in 1 patient group

Enhanced SVT discriminators

Other group

Description:

Patients with activated enhanced SVT discriminators (in accordance with predefined mandatory study settings)

Treatment:

Device: ICD with enhanced SVT discriminators