NCT02040675

Brief Summary

The purpose of this study is to validate a novel method of diagnosing arrhythmias using the NAVA catheter-positioning screen in patients who have a NAVA catheter in place.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

2.1 years

First QC Date

January 13, 2014

Last Update Submit

March 28, 2016

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • Types of cardiac arrhythmia

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population will be a convenience sample of adults with various arrhythmias who are scheduled to undergo an electrophysiology study and-or ablation (EPSA) under general anesthesia (GETA) at The Toledo Hospital.

You may qualify if:

  • Cardiac arrhythmia

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Promedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Howard Stein, MD

    Promedica Toledo CHildren's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Neonatology

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 20, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations

US(1)