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NCT00560768 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Sudden Cardiac Death, sponsored by LivaNova.

Completed
Registry status
Phase 4
Development phase
198
Enrollment target
20
Study locations

NCT00560768 is a Phase 4 study of Sudden Cardiac Death that has completed, run by LivaNova. The registered enrollment target is 198 participants, below the 1,398-participant average among 9 other Sudden Cardiac Death trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT00560768, a Phase 4 study of Sudden Cardiac Death, has completed, sponsored by LivaNova.

COMPLETED
Registry status
Phase 4
Development phase
198 participants
Enrollment target
20
Study locations

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 Studied

Interventions

  • DEVICE Ovatio VR 6250 or DR6550

Study Locations (20)

Other

  • Grey-Nuns Hospital - Edmonton
  • Hotel-Dieu du CHUM - Montreal
  • Laval UH, Ste Foy - Québec
  • St. Michael's Hospital - Toronto
  • Herz-und Diabeteszentrum NRW - Bad Oeynhausen
  • Praxis Westend - Berlin
  • Universitatsklinik Krankenanstalten Bergmannsheil - Bochum
  • Medizinische Universitatsklinik - Bonn
  • Klinikum - Coburg
  • Landkrankhenhaus Coburg - Coburg
  • Evangelisches Krankenhaus - Düsseldorf
  • Evangelisches Krankhenhaus Düsseldorf - Düsseldorf
  • Kardiocentrum - Frankfurt

Pennsylvania

  • Stafford M. Smith - Scranton Heart Institute - Clarks Green
  • Easton Cardiology - Easton

Alabama

  • Helen Kelle Hospital - Sheffield

California

  • Valley Regional Arrhytmia Center - Tarzana

Georgia

  • Piedmont Hospital - Atlanta

North Carolina

  • CMC - NorthEast - Charlotte

Ohio

  • Northwest Ohio Cardiology Consultants - Toledo

Trial Details

FieldValue
Enrollment Target 198 participants
Start Date 2007-12
Est. Completion 2012-10
Phase Phase 4

Sponsor

LivaNova

13 total trials

What the Registry Record Tells You About NCT00560768

The ClinicalTrials.gov registry entry for NCT00560768 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 198 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,398-participant average among 9 other Sudden Cardiac Death trials with a reported enrollment target (86% lower). The listed sponsor is LivaNova, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Sudden Cardiac Death appearing as the primary indexed condition, and to 1 intervention - of which Ovatio VR 6250 or DR6550 is the first listed.

NCT00560768 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, Pennsylvania, Alabama.

Frequently Asked Questions

What is clinical trial NCT00560768 about?

NCT00560768 is a clinical study titled "Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications". 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.

What is the current status of trial NCT00560768?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 198 participants. The study started on 2007-12. Estimated completion is 2012-10.

What conditions does trial NCT00560768 study?

This clinical trial studies the following conditions: Sudden Cardiac Death.

What interventions are being tested in trial NCT00560768?

The interventions under investigation include: Ovatio VR 6250 or DR6550 (DEVICE).

Who is sponsoring clinical trial NCT00560768?

This trial is sponsored by LivaNova, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00560768 being conducted?

This trial has 20 study locations across Alabama, California, Georgia, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.