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)
Sponsor:
Collaborator:
Sorin Group France SAS
Information provided by (Responsible Party):
LivaNova
ClinicalTrials.gov Identifier:
NCT01169246
First received: July 22, 2010
Last updated: February 23, 2015
Last verified: February 2015
  Purpose
Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.

Condition
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 ] [ Designated as safety issue: No ]
    % of VT episode successfully reduced by the ATP Auto-switch


Secondary Outcome Measures:
  • Arrhythmia incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts
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%.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169246

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

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT01169246     History of Changes
Other Study ID Numbers: RTGX02-ASAP  RTGX02 
Study First Received: July 22, 2010
Last Updated: February 23, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by LivaNova:
ATP,CRT, ICD PARADYM

ClinicalTrials.gov processed this record on July 28, 2016