Recurrent Atrial Fibrillation | NCT02898545

Studies
Recurrent Atrial Fibrillation

NCT02898545

Sponsor

University of Cincinnati

Status

Completed

Last Update Posted

Aug 1, 2017Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

SEEQ monitor

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

Jul 2017

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

Sep 2016

Primary Completion Date

Jul 20, 2017Actual

Completion Date

Jul 20, 2017Actual

First Submitted Date

Sep 8, 2016

First Submission Date that Met QC Criteria

Sep 12, 2016

First Posted Date

Sep 13, 2016Estimated

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

Jul 28, 2017

Last Update Posted Date

Aug 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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 study will evaluate the recurrence rates of atrial fibrillation that develops in the hospital following non cardiac procedures or surgeries or acute medical illnesses.

Detailed Description

Eligible individuals with no previous history of atrial fibrillation or flutter who develop a limited episode of atrial fibrillation during a hospital stay for an acute medical illness or non-cardiothoracic surgery or procedure. Patients will be monitored for a period of 1 month using Medtronic SEEQ monitors for recurrence. Subjects will self assign to wear the SEEQ monitor or standard of care. Individuals with implanted cardiac devices capable of detecting atrial fibrillation will also be included.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SEEQ monitor	Other	Subjects will be monitored via use of the SEEQ monitor	Device: SEEQ monitor
Standard of care	No Intervention	Subjects will not wear the SEEQ monitor or may have a pre-existing implanted device capable of detecting atrial fibrillation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SEEQ monitor	Device	An external cardiac rhythm monitor	SEEQ monitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence of atrial fibrillation	The rate of recurrence of atrial fibrillation will be compared to the recurrence noted in the standard of care arm.	28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Development of atrial fibrillation or flutter during a hospital stay following a non-cardiac procedure or acute medical illness
CHADS2VASc score of 2 or more

Exclusion Criteria:

Prior history of atrial fibrillation of flutter
Requiring ventilator support or in shock
Acute decompensated heart failure or EF =/< 40%
Greater than mild valvular heart disease
Other structural heart disease such as more than mild LVH, constrictive or restrictive cardiomyopathy
Hyperthyroidism uncontrolled at the time of diagnosis if known
Pulmonary embolism that requires thrombolysis or resulted in shock
Use of antiarrhythmic drugs (class I or III) at the time of discharge
Cardiothoracic surgery in the last 6 months

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mehran Attari, MD	University of Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cincinnati Medical Center		Cincinnati	Ohio	45219	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided