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Clinical Trials/NCT01169246
NCT01169246TerminatedNot Applicable

Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D Implanted Patients

MicroPort CRM1 site in 1 country1,254 target enrollmentStarted: November 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
1,254
Locations
1
Primary Endpoint
Ventricular Tachyarrhythmia episode
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Detailed Description

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Ventricular Tachyarrhythmia episode

Time Frame: 2 years

% of VT episode successfully reduced by the ATP Auto-switch

Secondary Outcomes

  • Arrhythmia incidence(2 years)

Investigators

Sponsor
MicroPort CRM
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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