Data Collection and Analysis of Patients Who Have Had an... | NCT00825968

Studies
Data Collection and Analysis of Patients Who Have Had an Electrophysiological Procedure

NCT00825968

Sponsor

Emile Daoud

Status

Terminated

Last Update Posted

Sep 20, 2011Estimated

Enrollment

58Actual

Phase

Not provided

Conditions

Heart Disease
Atrial Fibrillation

Interventions

Not provided

Countries

United States

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

Sep 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI stopped study to make a more substantial database.

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Jul 2009Actual

First Submitted Date

Jan 16, 2009

First Submission Date that Met QC Criteria

Jan 20, 2009

First Posted Date

Jan 21, 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

Sep 16, 2011

Last Update Posted Date

Sep 20, 2011Estimated

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

The purpose of the database is to complete outcomes research of electrophysiological procedures.

Detailed Description

The purpose of the database is to complete outcomes research (risk factors, follow-up, procedural data) Perhaps the most important research for any busy clinical laboratory is to appreciate the tendencies and trends that are occurring in their own laboratory setting. This will have a tremendous impact on educating the OSU staff as well as perhaps other centers on best medical practices.

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

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Data collection group		Patients having procedures done at the electrophysiology Laboratories at the Ross Heart Hospital at The Ohio State University Medical Center.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age and older
have or had a procedure preformed in the Electrophysiology Laboratories at the Ross Heart Hospital
Ability to consent

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients having procedures completed at the electrophysiology Laboratories at the Ross Heart Hospital at The Ohio State University Medical Center.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emile Daoud, MD	Ohio State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State University Medical Center		Columbus	Ohio	43210	United States

Condition Browse Module

MeSH Terms

ID	Term
D006331	Heart Diseases
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases
D001145	Arrhythmias, Cardiac
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided