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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)

This study has been terminated.
(Low recruitement rate)
Sorin Group France SAS
Information provided by (Responsible Party):
LivaNova Identifier:
First received: July 22, 2010
Last updated: February 23, 2015
Last verified: February 2015
Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.

Ventricular Arrythmias

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D Implanted Patients

Further study details as provided by LivaNova:

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

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

Enrollment: 1254
Study Start Date: November 2009
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Paradym VR, DR and CRT models

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

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01169246

CHU Brest
Brest, France
Sponsors and Collaborators
Sorin Group France SAS
Principal Investigator: SAVOURE Arnaud, MD CHU Rouen
  More Information

Responsible Party: LivaNova Identifier: NCT01169246     History of Changes
Other Study ID Numbers: RTGX02-ASAP
Study First Received: July 22, 2010
Last Updated: February 23, 2015

Keywords provided by LivaNova:
ATP,CRT, ICD PARADYM processed this record on August 16, 2017