Data Collection - Atrial Fibrillation Exploratory Study

Overview

About this study

The purpose of this study is to characterize the impact of Atrial fibrillation (AFib) and Atrial Flutter (AFl) on signals measured using a wearable Insertable Cardiac Monitor (ICM) prototype device.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Able to understand and willing to provide written informed consent to participate in the trial.
  • Age 18 years old or greater.
  • Willing and able to participate in study visits and the required testing.
  • Primary diagnosis of AFib or AFl and scheduled for a cardiac ablation or electrical cardioversion procedure.
  • Confirmed not in a normal heart rhythm at the time of enrollment.

Exclusion Criteria:

  • Currently enrolled in another clinical trial that may interfere with the placement of study system or include the usage of unapproved drugs.
  • Participant is pregnant or planning to become pregnant during the study.
  • Diagnosed with permanent AFib.
  • Active Implantable Medical Device, e.g. cardiac implantable electronic devices, bladder stimulators, diaphragm stimulators, implantable neuro stimulator, implantable active monitoring devices, implantable active drug administration devices, etc.
  • Known allergy to materials used in the study (adhesive tape, ECG electrodes).
  • Have a prosthetic cardiac valve or previously underwent cardiac valve surgery.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bruce Johnson, Ph.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Jennifer Isautier CCRP

(507) 266-2696

Isautier.Jennifer@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available