Overview

This trial has been completed.

Condition tachycardia
Treatment paradym dr model 8550; paradym crt model 8750; paradym rf dr model 9550; paradym rf crt model 9750; paradym rf crt sonr model 9770
Phase phase 4
Sponsor LivaNova
Start date October 2011
End date August 2015
Trial size 1013 participants
Trial identifier NCT01410552, ISIS ICD - ITSY09

Summary

ISIS- ICD study has been designed to evaluate the impact of PARAD+ algorithm on inappropriate shocks, in a general population implanted for primary or secondary prevention with a dual or tri chamber device at one year follow-up

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator
paradym dr model 8550; paradym crt model 8750; paradym rf dr model 9550; paradym rf crt model 9750; paradym rf crt sonr model 9770
PARADYM ICD and CRT-d with PARAD+ algorithm available

Primary Outcomes

Measure
Percentage of patient with inappropriate shock
time frame: 1 year

Secondary Outcomes

Measure
Appropriate shock
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patient eligible for implantation (according to current accepted guidelines, or scheduled for implant (primo-implant, replacement, upgrade) with a Paradym/Paradym RF (CRT-D or DR-ICD) within the next 30 days, or has already been implanted within the last 30 days 2. Patient in sinus rhythm, or patients with paroxysmal atrial tachyarrhythmia or patients with persistent atrial tachyarrhythmia in whom a cardioversion is planned within three months Exclusion Criteria: 1. Any contraindication for ICD therapy 2. Atrial lead not implanted 3. Patient with permanent atrial tachyarrhythmia 4. Patients implanted with a ventricular assist device (VAD)

Additional Information

Official title Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
Principal investigator Ricardo RUIZ GRANELL, Dr
Description The primary endpoint is to demonstrate that 95% of patients implanted with PARAD+ algorithm are free from inapproporiate shock compared to 92.5% in general ICD population.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by LivaNova.