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

Primary Purpose

Sudden Cardiac Death

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ovatio VR 6250 or DR6550
Sponsored by
LivaNova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sudden Cardiac Death focused on measuring 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.

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

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.

Sites / Locations

  • Helen Kelle Hospital
  • Valley Regional Arrhytmia Center
  • Piedmont Hospital
  • CMC - NorthEast
  • Northwest Ohio Cardiology Consultants
  • Stafford M. Smith - Scranton Heart Institute
  • Easton Cardiology
  • Grey-Nuns Hospital
  • Hotel-Dieu du CHUM
  • Laval UH, Ste Foy
  • St. Michael's Hospital
  • Herz-und Diabeteszentrum NRW
  • Praxis Westend
  • Universitatsklinik Krankenanstalten Bergmannsheil
  • Medizinische Universitatsklinik
  • Klinikum
  • Landkrankhenhaus Coburg
  • Evangelisches Krankenhaus
  • Evangelisches Krankhenhaus Düsseldorf
  • Kardiocentrum
  • Kardiocentrum Frankfurt, Klinik Rotes Kreuz
  • Städt Klinikum Lüneburg
  • Johannes Gutenberg-Universitat
  • Universitatklinikum Mainz
  • Bogenhausen Städt. Krankenhaus
  • Krankenhaus Reinbeck St Adolf-Stift
  • ST. Adolf Stift; Medizinische Klinik
  • Medizinische Klinik und Poliklinik I / kardiologie
  • Universitätsklinikum Würzburg
  • Universitario La Fe

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

TAV score and number of tachyarrhythmic events.

Secondary Outcome Measures

TAV change

Full Information

First Posted
November 19, 2007
Last Updated
January 9, 2015
Sponsor
LivaNova
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1. Study Identification

Unique Protocol Identification Number
NCT00560768
Brief Title
Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
Acronym
Prediction
Official Title
Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
LivaNova

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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.

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ovatio VR 6250 or DR6550
Intervention Description
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.
Primary Outcome Measure Information:
Title
TAV score and number of tachyarrhythmic events.
Time Frame
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 Measure Information:
Title
TAV change
Time Frame
12 months of follow up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BRACHMANN Johannes, PhD
Organizational Affiliation
Klinikum Coburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helen Kelle Hospital
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Valley Regional Arrhytmia Center
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
CMC - NorthEast
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Northwest Ohio Cardiology Consultants
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43615
Country
United States
Facility Name
Stafford M. Smith - Scranton Heart Institute
City
Clarks Green
State/Province
Pennsylvania
ZIP/Postal Code
18411-2326
Country
United States
Facility Name
Easton Cardiology
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18042
Country
United States
Facility Name
Grey-Nuns Hospital
City
Edmonton
ZIP/Postal Code
X0C0B0
Country
Canada
Facility Name
Hotel-Dieu du CHUM
City
Montreal
ZIP/Postal Code
H2W1T8
Country
Canada
Facility Name
Laval UH, Ste Foy
City
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
ZIP/Postal Code
M5B1W8
Country
Canada
Facility Name
Herz-und Diabeteszentrum NRW
City
Bad Oeynhausen
ZIP/Postal Code
D-32545
Country
Germany
Facility Name
Praxis Westend
City
Berlin
ZIP/Postal Code
10050
Country
Germany
Facility Name
Universitatsklinik Krankenanstalten Bergmannsheil
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Medizinische Universitatsklinik
City
Bonn
ZIP/Postal Code
D-53127
Country
Germany
Facility Name
Klinikum
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Landkrankhenhaus Coburg
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Evangelisches Krankenhaus
City
Dusseldorf
ZIP/Postal Code
40217
Country
Germany
Facility Name
Evangelisches Krankhenhaus Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40217
Country
Germany
Facility Name
Kardiocentrum
City
Frankfurt
ZIP/Postal Code
60316
Country
Germany
Facility Name
Kardiocentrum Frankfurt, Klinik Rotes Kreuz
City
Frankfurt
ZIP/Postal Code
D-60316
Country
Germany
Facility Name
Städt Klinikum Lüneburg
City
Lüneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Johannes Gutenberg-Universitat
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Universitatklinikum Mainz
City
Mainz
ZIP/Postal Code
D-55101
Country
Germany
Facility Name
Bogenhausen Städt. Krankenhaus
City
München
ZIP/Postal Code
81925
Country
Germany
Facility Name
Krankenhaus Reinbeck St Adolf-Stift
City
Reinbeck
ZIP/Postal Code
21465
Country
Germany
Facility Name
ST. Adolf Stift; Medizinische Klinik
City
Reinbek
ZIP/Postal Code
21465
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik I / kardiologie
City
Wurzburg
ZIP/Postal Code
D-97080
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Universitario La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain

12. IPD Sharing Statement

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

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