Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination (ISIS-ICD)

MicroPort

Status: Completed

Conditions: Tachycardia

Treatments: Device: PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770

Study type: Interventional

Funder types: Industry

Identifiers

NCT01410552

ISIS ICD - ITSY09

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,013 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,013 participants in 1 patient group

ICD or CRT-D with PARAD+

Other group

Description:

only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator

Treatment:

Device: PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770