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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00560768
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : January 12, 2015
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sudden Cardiac Death Device: Ovatio VR 6250 or DR6550 Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
Study Start Date : December 2007
Actual Primary Completion Date : August 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Experimental: 1 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.

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. TAV change [ Time Frame: 12 months of follow up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


  • 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.

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 identifier (NCT number): NCT00560768

United States, Alabama
Helen Kelle Hospital
Sheffield, Alabama, United States, 35660
United States, California
Valley Regional Arrhytmia Center
Tarzana, California, United States, 91356
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
United States, North Carolina
CMC - NorthEast
Charlotte, North Carolina, United States, 28025
United States, Ohio
Northwest Ohio Cardiology Consultants
Toledo, Ohio, United States, 43615
United States, Pennsylvania
Stafford M. Smith - Scranton Heart Institute
Clarks Green, Pennsylvania, United States, 18411-2326
Easton Cardiology
Easton, Pennsylvania, United States, 18042
Grey-Nuns Hospital
Edmonton, Canada, X0C0B0
Hotel-Dieu du CHUM
Montreal, Canada, H2W1T8
Laval UH, Ste Foy
Quebec, Canada, G1V4G5
St. Michael's Hospital
Toronto, Canada, M5B1W8
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, Germany, D-32545
Praxis Westend
Berlin, Germany, 10050
Universitatsklinik Krankenanstalten Bergmannsheil
Bochum, Germany, 44789
Medizinische Universitatsklinik
Bonn, Germany, D-53127
Coburg, Germany, 96450
Landkrankhenhaus Coburg
Coburg, Germany, 96450
Evangelisches Krankenhaus
Dusseldorf, Germany, 40217
Evangelisches Krankhenhaus Düsseldorf
Düsseldorf, Germany, 40217
Frankfurt, Germany, 60316
Kardiocentrum Frankfurt, Klinik Rotes Kreuz
Frankfurt, Germany, D-60316
Städt Klinikum Lüneburg
Lüneburg, Germany, 21339
Johannes Gutenberg-Universitat
Mainz, Germany, 55101
Universitatklinikum Mainz
Mainz, Germany, D-55101
Bogenhausen Städt. Krankenhaus
München, Germany, 81925
Krankenhaus Reinbeck St Adolf-Stift
Reinbeck, Germany, 21465
ST. Adolf Stift; Medizinische Klinik
Reinbek, Germany, 21465
Medizinische Klinik und Poliklinik I / kardiologie
Wurzburg, Germany, D-97080
Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Universitario La Fe
Valencia, Spain, 46009
Sponsors and Collaborators
Principal Investigator: BRACHMANN Johannes, PhD Klinikum Coburg

Responsible Party: KOLB / Principal investigator, Klinikum Coburg Identifier: NCT00560768     History of Changes
Other Study ID Numbers: Prediction - ITAC06 Eu
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: January 12, 2015
Last Verified: January 2015

Keywords provided by LivaNova:
Risk stratification method, negative predictive value, fast ventricular arrhythmias, ICD
The negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden