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

Sponsor

LivaNova (Industry)

Overall Status

Completed

CT.gov ID

NCT00560768

Collaborator

(none)

198

Enrollment

Locations

Arm

Duration (Months)

6.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sudden Cardiac Death	Device: Ovatio VR 6250 or DR6550	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

198 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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.

Arm

Intervention/Treatment

Experimental: 1

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.

Outcome Measures

Primary Outcome Measures

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

TAV change [12 months of follow up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helen Kelle Hospital	Sheffield	Alabama	United States	35660
2	Valley Regional Arrhytmia Center	Tarzana	California	United States	91356
3	Piedmont Hospital	Atlanta	Georgia	United States	30309
4	CMC - NorthEast	Charlotte	North Carolina	United States	28025
5	Northwest Ohio Cardiology Consultants	Toledo	Ohio	United States	43615
6	Stafford M. Smith - Scranton Heart Institute	Clarks Green	Pennsylvania	United States	18411-2326
7	Easton Cardiology	Easton	Pennsylvania	United States	18042
8	Grey-Nuns Hospital	Edmonton		Canada	X0C0B0
9	Hotel-Dieu du CHUM	Montreal		Canada	H2W1T8
10	Laval UH, Ste Foy	Quebec		Canada	G1V4G5
11	St. Michael's Hospital	Toronto		Canada	M5B1W8
12	Herz-und Diabeteszentrum NRW	Bad Oeynhausen		Germany	D-32545
13	Praxis Westend	Berlin		Germany	10050
14	Universitatsklinik Krankenanstalten Bergmannsheil	Bochum		Germany	44789
15	Medizinische Universitatsklinik	Bonn		Germany	D-53127
16	Klinikum	Coburg		Germany	96450
17	Landkrankhenhaus Coburg	Coburg		Germany	96450
18	Evangelisches Krankenhaus	Dusseldorf		Germany	40217
19	Evangelisches Krankhenhaus Düsseldorf	Düsseldorf		Germany	40217
20	Kardiocentrum	Frankfurt		Germany	60316
21	Kardiocentrum Frankfurt, Klinik Rotes Kreuz	Frankfurt		Germany	D-60316
22	Städt Klinikum Lüneburg	Lüneburg		Germany	21339
23	Johannes Gutenberg-Universitat	Mainz		Germany	55101
24	Universitatklinikum Mainz	Mainz		Germany	D-55101
25	Bogenhausen Städt. Krankenhaus	München		Germany	81925
26	Krankenhaus Reinbeck St Adolf-Stift	Reinbeck		Germany	21465
27	ST. Adolf Stift; Medizinische Klinik	Reinbek		Germany	21465
28	Medizinische Klinik und Poliklinik I / kardiologie	Wurzburg		Germany	D-97080
29	Universitätsklinikum Würzburg	Würzburg		Germany	97080
30	Universitario La Fe	Valencia		Spain	46009

Sponsors and Collaborators

LivaNova

Investigators

Principal Investigator: BRACHMANN Johannes, PhD, Klinikum Coburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00560768

Other Study ID Numbers:

Prediction - ITAC06 Eu
ITAC06 Eu

First Posted:

Nov 20, 2007

Last Update Posted:

Jan 12, 2015

Last Verified:

Jan 1, 2015

Keywords provided by , ,

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.

Additional relevant MeSH terms:

Death, Sudden, Cardiac

Death

Study Results

No Results Posted as of Jan 12, 2015