Atrial Fibrillation, Atrial Flutter
Conditions
Keywords
atrial fibrillation, atrial flutter, arrhythmia
Brief summary
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.
Detailed description
The is a non-randomized feasibility study that will enroll up to 50 participants with an ongoing episode of AFib/AFl and are referred for a cardiac ablation or electrical cardioversion procedure. A maximum of 20 persistent AFib, 20 paroxysmal AFib, and 20 AFl participants will be enrolled, not to exceed 50 total. There will be up to three data collection visits. Visit 1 will occur on the same day as enrollment and prior to the cardiac ablation or electrical cardioversion procedure. This allows collection of physiologic signals while the patient is in AFib or AFI. Visit 2 will occur after the cardiac ablation or electrical cardioversion procedure; no earlier than the day after the cardiac ablation or electrical cardioversion procedure and no more than 4 months after the day of the procedure. Visit 3 is optional, and may be scheduled upon sponsor's request, which will take place at least 5 months after the previous (second) data collection visit.
Interventions
DEVICEWearable cardiac monitor
Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * 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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiologic Signal Detection | 12 months | Characterize the impact of Atrial fibrillation (AFib) and Atrial Flutter (AFl) on signals measured using a wearable cardiac monitor prototype device. |
Countries
United States
Outcome results
None listed