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Non Invasive Arrhythmia Detection in Hospital Settings (EVE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00919087
First Posted: June 12, 2009
Last Update Posted: February 4, 2010
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.
Information provided by:
Corventis, Inc.
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00919087


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

Responsible Party: Madhuri Bhat, VP Regulatory and Clinical affairs, Corventis
ClinicalTrials.gov Identifier: NCT00919087     History of Changes
Other Study ID Numbers: COR-2009-002
First Submitted: June 10, 2009
First Posted: June 12, 2009
Last Update Posted: February 4, 2010
Last Verified: February 2010