Non Invasive Arrhythmia Detection in Hospital Settings

Arrhythmias Clinical Trial

— EVE  

Official title:

Evaluating Ventricular Events With Adherent Patient Monitoring Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919087
• Other study ID #: COR-2009-002
• Status: Completed
• Phase: N/A
• First received: June 10, 2009
• Last updated: February 2, 2010
• Start date: April 2009
• Est. completion date: August 2009

Study information

• Verified date: February 2010
• Source: Corventis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmias

Intervention

Device:
• Avivo System
Non invasive external monitoring deive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Corventis, Inc.