Recurrent Atrial Fibrillation (Recurrent AF)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: SEEQ monitor

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SEEQ monitor; Subjects will be monitored via use of the SEEQ monitor	Device: SEEQ monitor; An external cardiac rhythm monitor
No Intervention: Standard of care; Subjects will not wear the SEEQ monitor or may have a pre-existing implanted device capable of detecting atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Mehran Attari, MD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): July 20, 2017
• Study Completion (Actual): July 20, 2017

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2015-2478

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes