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Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications (Prediction)

This study has been completed.
Sponsor:
Information provided by:
LivaNova
ClinicalTrials.gov Identifier:
NCT00560768
First received: November 19, 2007
Last updated: January 9, 2015
Last verified: January 2015

November 19, 2007
January 9, 2015
December 2007
August 2012   (final data collection date for primary outcome measure)
TAV score and number of tachyarrhythmic events. [ Time Frame: The two phases M0 - M12 and M12 - M24 will be examined separately. For each 12 months period the TAV score at its beginning and tachyarrhythmic events in the following 12 months will be assessed. The NPV will be calculated for both phases. ] [ Designated as safety issue: No ]
TAV score and number of tachyarrhythmic events. [ Time Frame: The two phases M0 - M12 and M12 - M24 will be examined separately. For each 12 months period the TAV score at its beginning and tachyarrhythmic events in the following 12 months will be assessed. The NPV will be calculated for both phases. ]
Complete list of historical versions of study NCT00560768 on ClinicalTrials.gov Archive Site
TAV change [ Time Frame: 12 months of follow up ] [ Designated as safety issue: No ]
TAV change [ Time Frame: 12 months of follow up ]
Not Provided
Not Provided
 
Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Sudden Cardiac Death
Device: Ovatio VR 6250 or DR6550

The study requires the implantation of locally approved material:

  • A right ventricular defibrillation lead
  • In case of use of a dual chamber ICD a right atrial pacing lead
  • A single chamber or dual chamber ICD manufactured by SORIN Group. At begin of the study this will be OVATIO VR model 6250 and OVATIO DR model 6550. Any new devices of same type manufactured by SORIN Group which will become locally approved during the conduction of the trial can be used in the study.

Holter recording will be performed with a market approved recording system allowing high resolution ECG recording compatible with the analysis software for TVar.

Experimental: 1
Intervention: Device: Ovatio VR 6250 or DR6550
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
198
October 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patient has been prescribed the implantation of an SORIN GROUP OvatioTM DR 6550 / VR 6250 system according to relevant currently-approved guidelines

  • CHF since > 3 months and
  • LVEF < 35% and
  • NYHA class II or III

OR

  • Prior Myocardial infarction since more than 4 weeks and
  • LVEF < 30%

Exclusion Criteria:

  • Documented spontaneous sustained ventricular tachycardia
  • Prior implant of any device for ventricular cardiac pacing
  • Existing indication for permanent ventricular pacing
  • Myocardial infarction within 4 weeks prior to enrollment
  • Arrhythmogenic RV-Dysplasia
  • Brugada syndrome
  • Long QT syndrome
  • Performed within 3 months prior to enrollment or scheduled (within 3 months) cardiac revascularization (interventional or surgical)
  • Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
  • Excisting or planned administration of amiodarone - initiation of amiodarone therapy during the run of the study will lead to immediate exclusion of the patient
  • Permanent chronic atrial fibrillation / flutter
  • Patient is unable to attend the scheduled follow-up visits at the participating centre
  • Patient is already included in another ongoing clinical study
  • Patient is unable to understand the objectives of the study
  • Patient refuses to cooperate
  • Patient is unable or refuses to provide informed consent
  • Patient is minor (less than 18-year old)
  • Patient has life expectancy of less than 1 year
  • Patient is pregnant.
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Spain
 
NCT00560768
Prediction - ITAC06 Eu, ITAC06 Eu
No
Not Provided
Not Provided
KOLB / Principal investigator, Klinikum Coburg
LivaNova
Not Provided
Principal Investigator: BRACHMANN Johannes, PhD Klinikum Coburg
LivaNova
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP