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

NCT00560768 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2015-01-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • LivaNova

    lead INDUSTRY

Principal Investigators

  • BRACHMANN Johannes, PhD · Klinikum Coburg

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2012-08-31
Completion
2012-10-31

Countries

  • United States
  • Canada
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00560768 on ClinicalTrials.gov