Overview

This trial has been completed.

Condition tachycardia
Treatment icd with enhanced svt discriminators
Sponsor St. Jude Medical
Start date August 2013
End date October 2016
Trial size 735 participants
Trial identifier NCT01963286, CR-12-092-GE-HV

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Patients with activated enhanced SVT discriminators (in accordance with predefined mandatory study settings)
icd with enhanced svt discriminators Ellipse (St. Jude Medical)
ICD will be programmed to uniform device settings with enhanced SVT discrimintators enabled.

Primary Outcomes

Measure
Inappropriate ICD shocks
time frame: 12 months

Secondary Outcomes

Measure
ICD shocks for any reason
time frame: 12 months
Inappropriate ICD therapies
time frame: 12 months
Untreated VT/VF
time frame: 12 months
Accuracy of ICD therapy decision
time frame: 12 months
Specificity
time frame: 12 months
Cardiac deaths
time frame: 12 months
Sensitivity
time frame: 12 months
ICD/CRT-D related SAE
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.