Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02257112|
Recruitment Status : Completed
First Posted : October 6, 2014
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Multistage low-energy stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||June 30, 2016|
|Actual Study Completion Date :||June 30, 2016|
Experimental: 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.
Device: Multistage low-energy stimulation
The parameters of the Multistage waveform will be altered and the response of the atria will be recorded.
- 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. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02257112
|Hôpital du Haut-Lévêque|