Non Invasive Arrhythmia Detection in Hospital Settings (EVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00919087
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : February 4, 2010
Information provided by:
Corventis, Inc.

Brief Summary:
This is a prospective, single center, non-randomized study to evaluate the arrhythmia detection performance during ventricular events.

Condition or disease Intervention/treatment
Arrhythmias Device: Avivo System

Detailed Description:
The system will continuously monitor the patient's cardiac activity which will be compared to standard telemetry system.

Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluating Ventricular Events With Adherent Patient Monitoring Study
Study Start Date : April 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Intervention Details:
  • Device: Avivo System
    Non invasive external monitoring deive
    Other Name: external monitoring systems

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00919087

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

Responsible Party: Madhuri Bhat, VP Regulatory and Clinical affairs, Corventis Identifier: NCT00919087     History of Changes
Other Study ID Numbers: COR-2009-002
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2010