Clinical trial NCT00560768: Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
Official title: Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sudden Cardiac Death
Keywords: Risk stratification method, negative predictive value, fast ventricular arrhythmias, ICD
The negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2007-11-20
Enrollment: 198
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: TAV score and number of tachyarrhythmic events.
timeFrame: 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:
measure: TAV change
timeFrame: 12 months of follow up
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Helen Kelle Hospital
state: Alabama
city: Tarzana
country: United States
facility: Valley Regional Arrhytmia Center
state: California
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Charlotte
country: United States
facility: CMC - NorthEast
state: North Carolina
city: Toledo
country: United States
facility: Northwest Ohio Cardiology Consultants
state: Ohio
city: Clarks Green
country: United States
facility: Stafford M. Smith - Scranton Heart Institute
state: Pennsylvania
city: Easton
country: United States
facility: Easton Cardiology
state: Pennsylvania
city: Edmonton
country: Canada
facility: Grey-Nuns Hospital
city: Montreal
country: Canada
facility: Hotel-Dieu du CHUM
city: Quebec
country: Canada
facility: Laval UH, Ste Foy
city: Toronto
country: Canada
facility: St. Michael's Hospital
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Praxis Westend
city: Bochum
country: Germany
facility: Universitatsklinik Krankenanstalten Bergmannsheil
city: Bonn
country: Germany
facility: Medizinische Universitatsklinik
city: Coburg
country: Germany
facility: Klinikum
city: Coburg
country: Germany
facility: Landkrankhenhaus Coburg
city: Dusseldorf
country: Germany
facility: Evangelisches Krankenhaus
city: Düsseldorf
country: Germany
facility: Evangelisches Krankhenhaus Düsseldorf
city: Frankfurt
country: Germany
facility: Kardiocentrum
city: Frankfurt
country: Germany
facility: Kardiocentrum Frankfurt, Klinik Rotes Kreuz
city: Lüneburg
country: Germany
facility: Städt Klinikum Lüneburg
city: Mainz
country: Germany
facility: Johannes Gutenberg-Universitat
city: Mainz
country: Germany
facility: Universitatklinikum Mainz
city: München
country: Germany
facility: Bogenhausen Städt. Krankenhaus
city: Reinbeck
country: Germany
facility: Krankenhaus Reinbeck St Adolf-Stift
city: Reinbek
country: Germany
facility: ST. Adolf Stift; Medizinische Klinik
city: Wurzburg
country: Germany
facility: Medizinische Klinik und Poliklinik I / kardiologie
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Valencia
country: Spain
facility: Universitario La Fe
Study officials:
affiliation: Klinikum Coburg
name: BRACHMANN Johannes, PhD
role: PRINCIPAL_INVESTIGATOR
References: