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Efficacy of the ATP Switch Automatic Programming in Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) Implanted Patients

NCT ID: NCT01169246

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1254 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2015-02-28

Brief Summary

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Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.

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Detailed Description

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The efficacy rate of the ATP Auto-switch function, defined as the % of VT episodes successfully reduced, will be compared with 85%.

Conditions

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Ventricular Arrythmias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Paradym VR, DR and CRT models

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* The patient has been implanted (primo implantation or replacement) with an ICD model PARADYM VR 8250, DR 8550, CRT 8750, CRT 8770 models or any similar or higher range device
* ATP Auto-switch function is programmed ON

Exclusion Criteria

* Presence of a contra-indication to the ICD therapy
* Life expectancy less than 12 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sorin Group France SAS

UNKNOWN

Sponsor Role collaborator

MicroPort CRM

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SAVOURE Arnaud, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Locations

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CHU Brest

Brest, , France

Site Status

Countries

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France

Other Identifiers

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RTGX02

Identifier Type: -

Identifier Source: secondary_id

RTGX02-ASAP

Identifier Type: -

Identifier Source: org_study_id

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