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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sorin Group France SAS
Information provided by (Responsible Party):
Sorin Group
ClinicalTrials.gov Identifier:
NCT01169246
First received: July 22, 2010
Last updated: June 4, 2014
Last verified: July 2010
  Purpose

This study consists in a non-interventional multi-center, prospective study. Primary objective is to assess the efficacy of the new ATP Autoswitch function.


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 Sorin Group:

Primary Outcome Measures:
  • Ventricular arrhythmia reduction [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1775
Study Start Date: November 2009
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Paradym VR, DR and CRT models

Detailed Description:

The previous range of ICD CRT-systems implements an ATP function, which is designed to reduce the amount of time required to reduce an arrhythmia.

When the device detects the first ventricular tachycardia requiring therapy, it applies the first ATP program and any subsequent programs to reduce the arrhythmia. When the next ventricular tachycardia episode occurs, the device always starts with the same ATP program than the first time.

The new ATP Auto-switch function has been designed in order to increase ATP efficacy towards ventricular arrhythmias (in slow VT and VT zones, i.e. below 200 bpm) reduction as described below, avoiding, if efficient, painful shock therapy:

2 different ATP programs (ATP1 and ATP2) must be programmed in the slow VT and VT zones. When the device detects the first ventricular tachycardia requiring therapy, it applies the first ATP program (ATP1) and the second ATP program (ATP2) if the first attempt was unsuccessful. If ATP1 was applied and was not efficient and ATP2 was applied and was efficient, there is a switch on the next ventricular tachycardia episode: the device starts automatically with ATP2 as a first attempt, followed by ATP1 as a second attempt if necessary

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A total of 1775 patients are required to demonstrate the main objective (global 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
  • The patient has read and understood the patient information

Exclusion Criteria:

  • Presence of a contra-indication to the ICD therapy
  • Life expectancy less than 12 months
  • Inability or refusal to provide informed consent to the data treatment
  • Not available for routine follow-up visits
  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
Sorin Group
Sorin Group France SAS
Investigators
Principal Investigator: SAVOURE Arnaud, MD CHU Rouen
  More Information

No publications provided

Responsible Party: Sorin Group
ClinicalTrials.gov Identifier: NCT01169246     History of Changes
Other Study ID Numbers: RTGX02-ASAP, RTGX02
Study First Received: July 22, 2010
Last Updated: June 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sorin Group:
ATP,CRT, ICD PARADYM

ClinicalTrials.gov processed this record on October 01, 2014