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

Completed · Phase 4

Conditions studied: Sudden Cardiac Death

In brief

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.

Key facts

Study ID

NCT00560768

Run by

LivaNova

People needed

198

Starts

2007-12-01

Expected to finish

2012-10-01

Last updated by the study team

2015-01-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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
• OR
• 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.
• 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.

Where it is running

• Helen Kelle Hospital — Sheffield, Alabama, United States
• Valley Regional Arrhytmia Center — Tarzana, California, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• CMC - NorthEast — Charlotte, North Carolina, United States
• Northwest Ohio Cardiology Consultants — Toledo, Ohio, United States
• Stafford M. Smith - Scranton Heart Institute — Clarks Green, Pennsylvania, United States
• Easton Cardiology — Easton, Pennsylvania, United States
• Grey-Nuns Hospital — Edmonton, Canada
• Hotel-Dieu du CHUM — Montreal, Canada
• Laval UH, Ste Foy — Québec, Canada
• St. Michael's Hospital — Toronto, Canada
• Herz-und Diabeteszentrum NRW — Bad Oeynhausen, Germany
• Praxis Westend — Berlin, Germany
• Universitatsklinik Krankenanstalten Bergmannsheil — Bochum, Germany
• Medizinische Universitatsklinik — Bonn, Germany
• Klinikum — Coburg, Germany
• Landkrankhenhaus Coburg — Coburg, Germany
• Evangelisches Krankenhaus — Düsseldorf, Germany
• Evangelisches Krankhenhaus Düsseldorf — Düsseldorf, Germany
• Kardiocentrum — Frankfurt, Germany
• Kardiocentrum Frankfurt, Klinik Rotes Kreuz — Frankfurt, Germany
• Städt Klinikum Lüneburg — Lüneburg, Germany
• Johannes Gutenberg-Universitat — Mainz, Germany
• Universitatklinikum Mainz — Mainz, Germany
• Bogenhausen Städt. Krankenhaus — München, Germany

Full record on ClinicalTrials.gov

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