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

Sudden Cardiac Death Clinical Trial

— Prediction  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560768
• Other study ID #: Prediction - ITAC06 Eu
• Secondary ID: ITAC06 Eu
• Status: Completed
• Phase: Phase 4
• First received: November 19, 2007
• Last updated: January 9, 2015
• Start date: December 2007
• Est. completion date: October 2012

Study information

• Verified date: January 2015
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Sudden Cardiac Death

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Grey-Nuns Hospital	Edmonton
Canada	Hotel-Dieu du CHUM	Montreal
Canada	Laval UH, Ste Foy	Quebec
Canada	St. Michael's Hospital	Toronto
Germany	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	Dusseldorf
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	Medizinische Klinik und Poliklinik I / kardiologie	Wurzburg
Germany	Universitätsklinikum Würzburg	Würzburg
Spain	Universitario La Fe	Valencia
United States	Piedmont Hospital	Atlanta	Georgia
United States	CMC - NorthEast	Charlotte	North Carolina
United States	Stafford M. Smith - Scranton Heart Institute	Clarks Green	Pennsylvania
United States	Easton Cardiology	Easton	Pennsylvania
United States	Helen Kelle Hospital	Sheffield	Alabama
United States	Valley Regional Arrhytmia Center	Tarzana	California
United States	Northwest Ohio Cardiology Consultants	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	TAV change		12 months of follow up	No