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

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.

Study Overview

• Status: Completed
• Conditions: Sudden Cardiac Death
• Intervention / Treatment: Device: Ovatio VR 6250 or DR6550

• Study Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
TAV score and number of tachyarrhythmic events.	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

Outcome Measure	Time Frame
TAV change	12 months of follow up

Collaborators and Investigators

• Sponsor: LivaNova
• Investigators: Principal Investigator: BRACHMANN Johannes, PhD, Klinikum Coburg

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: November 19, 2007
• First Submitted That Met QC Criteria: November 19, 2007
• First Posted (Estimate): November 20, 2007

Study Record Updates

• Last Update Posted (Estimate): January 12, 2015
• Last Update Submitted That Met QC Criteria: January 9, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: 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: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Heart Arrest; Death; Death, Sudden, Cardiac
• Other Study ID Numbers: Prediction - ITAC06 Eu; ITAC06 Eu