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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Sorin Group.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT00560768
First received: November 19, 2007
Last updated: January 11, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Sudden Cardiac Death
Device: Ovatio VR 6250 or DR6550
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications

Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • TAV change [ Time Frame: 12 months of follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 198
Study Start Date: December 2007
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00560768

Locations
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
Canada
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
Germany
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
Landkrankhenhaus Coburg
Coburg, Germany, 96450
Klinikum
Coburg, Germany, 96450
Evangelisches Krankenhaus
Dusseldorf, Germany, 40217
Evangelisches Krankhenhaus Düsseldorf
Düsseldorf, Germany, 40217
Kardiocentrum Frankfurt, Klinik Rotes Kreuz
Frankfurt, Germany, D-60316
Kardiocentrum
Frankfurt, Germany, 60316
Städt Klinikum Lüneburg
Lüneburg, Germany, 21339
Universitatklinikum Mainz
Mainz, Germany, D-55101
Johannes Gutenberg-Universitat
Mainz, Germany, 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
Spain
Universitario La Fe
Valencia, Spain, 46009
Sponsors and Collaborators
Sorin Group
Investigators
Principal Investigator: BRACHMANN Johannes, PhD Klinikum Coburg
  More Information

No publications provided

Responsible Party: KOLB / Principal investigator, Klinikum Coburg
ClinicalTrials.gov Identifier: NCT00560768     History of Changes
Other Study ID Numbers: Prediction - ITAC06 Eu, ITAC06 Eu
Study First Received: November 19, 2007
Last Updated: January 11, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Sorin Group:
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
Death
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014