Atrial Fibrillation
Conditions
Brief summary
An assessment of the use of cold therapy to terminate atrial fibrillation.
Interventions
OTHERCool therapy
Application of cool therapy. A chilled (between 5C and 10C) instrument will be applied to the oblique sinus while the patient is in atrial fibrillation.
Sponsors
MediCool Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be ≥ 18 years or older * Male of female * Subject has documented paroxysmal, or persistent atrial fibrillation (AF) with a history of less than one-year duration * Must be in AF at time of surgery, or inducible using manual or electrical stimulation * Subject is willing and able to provide written informed consent * Subject has a life expectancy of at least 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Termination of atrial fibrillation | Termination will be measured within 3 minutes of application of cool therapy. No longer term data will be collected. | Number of successful terminations of atrial fibrillation to normal sinus rhythm upon application of cool therapy will be measured and assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to termination | Time to termination will be assessed only during each application. No longer term data will be collected. | The time it takes (in minutes and seconds) to terminate atrial fibrillation to normal sinus rhythm will be measured following application of cool therapy. |
Contacts
Primary ContactJeff Rynbrandt
Outcome results
None listed