Back to resultsMeasurement of Low-energy Stimulation in Patients With Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multistage low-energy stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- patients indicated for an atrial fibrillation ablation procedure
Exclusion Criteria:
-
Sites / Locations
- Hôpital du Haut-Lévêque
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multistage low-energy stimulation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02257112
Brief Title
Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation
Official Title
Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
June 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardialen, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multistage low-energy stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Multistage low-energy stimulation
Intervention Description
The parameters of the Multistage waveform will be altered and the response of the atria will be recorded.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Patients will be followed during the acute procedure which is expected to average 60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients indicated for an atrial fibrillation ablation procedure
Exclusion Criteria:
-
Facility Information:
Facility Name
Hôpital du Haut-Lévêque
City
Bordeaux
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data. Data has been published in a peer reviewed journal
Citations:
PubMed Identifier
24076284
Citation
Janardhan AH, Gutbrod SR, Li W, Lang D, Schuessler RB, Efimov IR. Multistage electrotherapy delivered through chronically-implanted leads terminates atrial fibrillation with lower energy than a single biphasic shock. J Am Coll Cardiol. 2014 Jan 7-14;63(1):40-8. doi: 10.1016/j.jacc.2013.07.098. Epub 2013 Sep 26.
Results Reference
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Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation
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