Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
Prediction
2 other identifiers
interventional
198
4 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2007
Longer than P75 for phase_4
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2007
CompletedFirst Posted
Study publicly available on registry
November 20, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJanuary 12, 2015
January 1, 2015
4.7 years
November 19, 2007
January 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
TAV change
12 months of follow up
Study Arms (1)
1
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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.
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LivaNovalead
Study Sites (30)
Helen Kelle Hospital
Sheffield, Alabama, 35660, United States
Valley Regional Arrhytmia Center
Tarzana, California, 91356, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
CMC - NorthEast
Charlotte, North Carolina, 28025, United States
Northwest Ohio Cardiology Consultants
Toledo, Ohio, 43615, United States
Stafford M. Smith - Scranton Heart Institute
Clarks Green, Pennsylvania, 18411-2326, United States
Easton Cardiology
Easton, Pennsylvania, 18042, United States
Grey-Nuns Hospital
Edmonton, X0C0B0, Canada
Hotel-Dieu du CHUM
Montreal, H2W1T8, Canada
Laval UH, Ste Foy
Québec, G1V4G5, Canada
St. Michael's Hospital
Toronto, M5B1W8, Canada
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, D-32545, Germany
Praxis Westend
Berlin, 10050, Germany
Universitatsklinik Krankenanstalten Bergmannsheil
Bochum, 44789, Germany
Medizinische Universitatsklinik
Bonn, D-53127, Germany
Klinikum
Coburg, 96450, Germany
Landkrankhenhaus Coburg
Coburg, 96450, Germany
Evangelisches Krankenhaus
Düsseldorf, 40217, Germany
Evangelisches Krankhenhaus Düsseldorf
Düsseldorf, 40217, Germany
Kardiocentrum
Frankfurt, 60316, Germany
Kardiocentrum Frankfurt, Klinik Rotes Kreuz
Frankfurt, D-60316, Germany
Städt Klinikum Lüneburg
Lüneburg, 21339, Germany
Johannes Gutenberg-Universitat
Mainz, 55101, Germany
Universitatklinikum Mainz
Mainz, D-55101, Germany
Bogenhausen Städt. Krankenhaus
München, 81925, Germany
Krankenhaus Reinbeck St Adolf-Stift
Reinbeck, 21465, Germany
ST. Adolf Stift; Medizinische Klinik
Reinbek, 21465, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
Medizinische Klinik und Poliklinik I / kardiologie
Würzburg, D-97080, Germany
Universitario La Fe
Valencia, 46009, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
BRACHMANN Johannes, PhD
Klinikum Coburg
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 19, 2007
First Posted
November 20, 2007
Study Start
December 1, 2007
Primary Completion
August 1, 2012
Study Completion
October 1, 2012
Last Updated
January 12, 2015
Record last verified: 2015-01