Non Invasive Arrhythmia Detection in Hospital Settings | NCT00919087

Studies
Non Invasive Arrhythmia Detection in Hospital Settings

NCT00919087

Sponsor

Corventis, Inc.

Status

Completed

Last Update Posted

Feb 4, 2010Estimated

Enrollment

25Estimated

Phase

Not provided

Conditions

Arrhythmias

Interventions

Avivo System

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jun 10, 2009

First Submission Date that Met QC Criteria

Jun 11, 2009

First Posted Date

Jun 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2010

Last Update Posted Date

Feb 4, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Avivo System	Device	Non invasive external monitoring deive		external monitoring systems

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

electrophysiology (EP) study or implantable cardioverter defibrillator (ICD) implant Patients

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Imad Libbus, PhD	Corventis, Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided