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OpenTrials
Completed

NCT Number: NCT01410552

Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination

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

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Key information

Conditions

Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire D'Amiens, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

  • Any contraindication for ICD therapy
  • Atrial lead not implanted
  • Patient with permanent atrial tachyarrhythmia
  • Patients implanted with a ventricular assist device (VAD)

Treatment and study plan

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

Device

PARADYM ICD and CRT-d with PARAD+ algorithm available

Primary outcomes

  1. Patients With Inappropriate Shock(s)

    Time frame: 552 days

    Percentage of patients presenting with inappropriate shock(s)

Secondary outcomes

  1. Shock(s) Appropriately Delivered

    Time frame: 552 days

    Percentage of shocks appropriately delivered

Sponsors and collaborators

Lead sponsor

MicroPort CRM

Industry

Registry information

Acronym: ISIS-ICD

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Aug 5, 2011
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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