Back to resultsRecurrent Atrial Fibrillation (Recurrent AF)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SEEQ monitor
Sponsored by
About this trial
This is an interventional screening trial for Atrial Fibrillation
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
Sites / Locations
- University of Cincinnati Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
SEEQ monitor
Standard of care
Arm Description
Subjects will be monitored via use of the SEEQ monitor
Subjects will not wear the SEEQ monitor or may have a pre-existing implanted device capable of detecting atrial fibrillation
Outcomes
Primary Outcome Measures
Recurrence of atrial fibrillation
The rate of recurrence of atrial fibrillation will be compared to the recurrence noted in the standard of care arm.
Secondary Outcome Measures
Full Information
NCT ID
NCT02898545
First Posted
September 8, 2016
Last Updated
July 28, 2017
Sponsor
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT02898545
Brief Title
Recurrent Atrial Fibrillation
Acronym
Recurrent AF
Official Title
Recurrent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
July 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SEEQ monitor
Arm Type
Other
Arm Description
Subjects will be monitored via use of the SEEQ monitor
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Subjects will not wear the SEEQ monitor or may have a pre-existing implanted device capable of detecting atrial fibrillation
Intervention Type
Device
Intervention Name(s)
SEEQ monitor
Intervention Description
An external cardiac rhythm monitor
Primary Outcome Measure Information:
Title
Recurrence of atrial fibrillation
Description
The rate of recurrence of atrial fibrillation will be compared to the recurrence noted in the standard of care arm.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehran Attari, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Recurrent Atrial Fibrillation
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