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

Phase 4

Completed

• Conditions: Sudden Cardiac Death
• Interventions: Device: Ovatio VR 6250 or DR6550

• Registration Number: NCT00560768
• Lead Sponsor: LivaNova

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-20
• Study Start: 2007-12
• Primary Completion: 2012-08
• Study Completion: 2012-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-09
• Last Update Posted: 2015-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Ovatio VR 6250 or DR6550	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
TAV change	12 months of follow up

Trial Locations

Locations (30)

Piedmont Hospital; 🇺🇸 Atlanta, Georgia, United States

Medizinische Universitatsklinik; 🇩🇪 Bonn, Germany

Bogenhausen Städt. Krankenhaus; 🇩🇪 München, Germany

Universitatklinikum Mainz; 🇩🇪 Mainz, Germany

Medizinische Klinik und Poliklinik I / kardiologie; 🇩🇪 Wurzburg, Germany

Stafford M. Smith - Scranton Heart Institute; 🇺🇸 Clarks Green, Pennsylvania, United States

Evangelisches Krankenhaus; 🇩🇪 Dusseldorf, Germany

Kardiocentrum; 🇩🇪 Frankfurt, Germany

Kardiocentrum Frankfurt, Klinik Rotes Kreuz; 🇩🇪 Frankfurt, Germany

Valley Regional Arrhytmia Center; 🇺🇸 Tarzana, California, United States

Praxis Westend; 🇩🇪 Berlin, Germany

Universitario La Fe; 🇪🇸 Valencia, Spain

Laval UH, Ste Foy; 🇨🇦 Quebec, Canada

Easton Cardiology; 🇺🇸 Easton, Pennsylvania, United States

St. Michael's Hospital; 🇨🇦 Toronto, Canada

Klinikum; 🇩🇪 Coburg, Germany

Landkrankhenhaus Coburg; 🇩🇪 Coburg, Germany

Krankenhaus Reinbeck St Adolf-Stift; 🇩🇪 Reinbeck, Germany

Helen Kelle Hospital; 🇺🇸 Sheffield, Alabama, United States

Northwest Ohio Cardiology Consultants; 🇺🇸 Toledo, Ohio, United States

Hotel-Dieu du CHUM; 🇨🇦 Montreal, Canada

Evangelisches Krankhenhaus Düsseldorf; 🇩🇪 Düsseldorf, Germany

Städt Klinikum Lüneburg; 🇩🇪 Lüneburg, Germany

Johannes Gutenberg-Universitat; 🇩🇪 Mainz, Germany

ST. Adolf Stift; Medizinische Klinik; 🇩🇪 Reinbek, Germany

Grey-Nuns Hospital; 🇨🇦 Edmonton, Canada

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Germany

Herz-und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

CMC - NorthEast; 🇺🇸 Charlotte, North Carolina, United States

Universitatsklinik Krankenanstalten Bergmannsheil; 🇩🇪 Bochum, Germany