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Non Invasive Arrhythmia Detection in Hospital Settings (EVE)

This study has been completed.
Information provided by:
Corventis, Inc. Identifier:
First received: June 10, 2009
Last updated: February 2, 2010
Last verified: February 2010
This is a prospective, single center, non-randomized study to evaluate the arrhythmia detection performance during ventricular events.

Condition Intervention
Arrhythmias Device: Avivo System

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluating Ventricular Events With Adherent Patient Monitoring Study

Further study details as provided by Corventis, Inc.:

Estimated Enrollment: 25
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Avivo System
    Non invasive external monitoring deive
    Other Name: external monitoring systems
Detailed Description:
The system will continuously monitor the patient's cardiac activity which will be compared to standard telemetry system.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
electrophysiology (EP) study or implantable cardioverter defibrillator (ICD) implant Patients

Inclusion Criteria:

  • Is female or male, 18 years of age or older
  • Undergoing ICD implant with ventricular arrhythmia induction OR undergoing EP study with ventricular arrhythmia induction

Exclusion Criteria:

  • Is participating in another clinical study that may confound the results of this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00919087

Sponsors and Collaborators
Corventis, Inc.
Study Director: Imad Libbus, PhD Corventis, Inc.
  More Information

Responsible Party: Madhuri Bhat, VP Regulatory and Clinical affairs, Corventis Identifier: NCT00919087     History of Changes
Other Study ID Numbers: COR-2009-002
Study First Received: June 10, 2009
Last Updated: February 2, 2010 processed this record on August 22, 2017