Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation
Not Applicable
Completed
- Conditions
- Atrial Fibrillation
- Interventions
- Device: Multistage low-energy stimulation
- Registration Number
- NCT02257112
- Lead Sponsor
- Cardialen, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Inclusion Criteria
- patients indicated for an atrial fibrillation ablation procedure
Exclusion Criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Multistage low-energy stimulation Multistage low-energy stimulation Multistage low-energy electrical pulses as described in Janardhan AH et al. JACC 2014 Jan7-14:63(1):40-8 will be delivered to a patient in atrial fibrillation. The responses to these stimuli will be recorded.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hôpital du Haut-Lévêque
🇫🇷Bordeaux, France