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
Recruitment status was Active, not recruiting
Sponsor:
Sorin Group
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT00560768
First received: November 19, 2007
Last updated: January 11, 2011
Last verified: January 2011
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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:
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
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 May 16, 2013