Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination

MicroPort CRM1,013 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,013

Conditions

Tachycardia

Interventions

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

PARADYM ICD and CRT-d with PARAD+ algorithm available

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (80)

Outcomes

Primary Outcomes

Patients With Inappropriate Shock(s)

Percentage of patients presenting with inappropriate shock(s)

Time frame: 552 days

Secondary Outcomes

Shock(s) Appropriately Delivered

Percentage of shocks appropriately delivered

Time frame: 552 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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