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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 (ASAP)

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ClinicalTrials.gov Identifier: NCT01169246
Recruitment Status : Terminated (Low recruitement rate)
First Posted : July 26, 2010
Last Update Posted : February 25, 2015
Sponsor:
Collaborator:
Sorin Group France SAS
Information provided by (Responsible Party):
LivaNova

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

Condition or disease
Ventricular Arrythmias

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 Type : Observational
Actual Enrollment : 1254 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D Implanted Patients
Study Start Date : November 2009
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Group/Cohort
Paradym VR, DR and CRT models



Primary Outcome Measures :
  1. Ventricular Tachyarrhythmia episode [ Time Frame: 2 years ]
    % of VT episode successfully reduced by the ATP Auto-switch


Secondary Outcome Measures :
  1. Arrhythmia incidence [ Time Frame: 2 years ]
    DEvice based data



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICD/CRT-D implanted patients population
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169246


Locations
France
CHU Brest
Brest, France
Sponsors and Collaborators
LivaNova
Sorin Group France SAS
Investigators
Principal Investigator: SAVOURE Arnaud, MD CHU Rouen

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT01169246     History of Changes
Other Study ID Numbers: RTGX02-ASAP
RTGX02
First Posted: July 26, 2010    Key Record Dates
Last Update Posted: February 25, 2015
Last Verified: February 2015

Keywords provided by LivaNova:
ATP,CRT, ICD PARADYM