Data Collection Atrial Fibrillation Exploratory Study

Stopped early

Conditions studied: Atrial Fibrillation, Atrial Flutter

In brief

To characterize the impact of Atrial fibrillation (AFib) and Atrial Flutter (AFl) on signals measured using a wearable cardiac monitor prototype device. To evaluate the relationship of AFib/AFl symptom severity with various physiologic signals measured from the wearable cardiac monitor prototype device.

Key facts

Study ID: NCT03647085
Run by: Boston Scientific Corporation
People needed: 27
Starts: 2018-08-29
Expected to finish: 2019-01-10
Last updated by the study team: 2022-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Diagnosed with paroxysmal AFib or persistent AFib or AFl and scheduled for a cardiac ablation or electrical cardioversion procedure
Confirmed AFib/AFl at the time of enrollment

You may not qualify if…

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.

Where it is running

Mayo Clinic Foundation — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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