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

NCT ID: NCT00560768

Last Updated: 2015-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2012-10-31

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.

Conditions

Sudden Cardiac Death

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Ovatio VR 6250 or DR6550

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LivaNova

INDUSTRY

Sponsor Role: lead

Responsible Party

Klinikum Coburg

Principal Investigators

BRACHMANN Johannes, PhD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Coburg

Locations

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

Krankenhaus Reinbeck St Adolf-Stift

Reinbeck, , Germany

ST. Adolf Stift; Medizinische Klinik

Reinbek, , Germany

Universitätsklinikum Würzburg

Würzburg, , Germany

Medizinische Klinik und Poliklinik I / kardiologie

Würzburg, , Germany

Universitario La Fe

Valencia, , Spain

Countries

United States; Canada; Germany; Spain

Other Identifiers

ITAC06 Eu

Identifier Type: -

Identifier Source: secondary_id

Prediction - ITAC06 Eu

Identifier Type: -

Identifier Source: org_study_id