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Non Invasive Arrhythmia Detection in Hospital Settings (EVE)

This study has been completed.
Sponsor:
Information provided by:
Corventis, Inc.
ClinicalTrials.gov Identifier:
NCT00919087
First received: June 10, 2009
Last updated: February 2, 2010
Last verified: February 2010
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Arrhythmia
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919087

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

No publications provided

Responsible Party: Madhuri Bhat, VP Regulatory and Clinical affairs, Corventis
ClinicalTrials.gov Identifier: NCT00919087     History of Changes
Other Study ID Numbers: COR-2009-002
Study First Received: June 10, 2009
Last Updated: February 2, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013