Atrial Fibrillation
Conditions
Brief summary
Multistage low-energy pulses are being evaluated for their effect on atrial fibrillation during an acute testing procedure.
Detailed description
This is a research feasibility study to evaluate various parameters of the multistage low-energy pulses and their effect on atrial fibrillation.
Interventions
DEVICEMultistage low-energy stimulation
The parameters of the Multistage waveform will be altered and the response of the atria will be recorded.
Sponsors
Cardialen, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients indicated for an atrial fibrillation ablation procedure
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Efficacy of Multistage low-energy pulses to organize, suppress, or terminate atrial fibrillation as determined by changes in atrial fibrillation cycle length, and atrial electrogram morphology. | Patients will be followed during the acute procedure which is expected to average 60 minutes | Multistage low-energy pulses are delivered to the atria of patients while in atrial fibrillation. The atrial electrograms will be recorded and used to evaluate if there was a change in the atrial fibrillation cycle length, increased organization of the arrhythmia using frequency analysis or if the pulses were able to terminate the atrial fibrillation. |
Countries
France
Outcome results
None listed