NCT00560768

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

• Sudden Cardiac Death

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-12-01
• Primary completion: 2012-08-01
• Completion: 2012-10-01
• First posted: 2007-11-20
• Last updated: 2015-01-12

Locations

30 sites across 4 countries: United States, Canada, Germany, Spain