Data Collection Atrial Fibrillation Exploratory Study
| Status: | Recruiting |
|---|---|
| Conditions: | Atrial Fibrillation, Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2018 |
| Start Date: | September 1, 2018 |
| End Date: | December 2019 |
| Contact: | Ashley Jensen, MS |
| Email: | ashley.jensen@bsci.com |
| Phone: | 651.582.4908 |
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.
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.
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.
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.
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.
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