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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
Sponsor:
Information provided by (Responsible Party):
Cardialen, Inc.

Study Description
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Brief Summary:
Multistage low-energy pulses are being evaluated for their effect on atrial fibrillation during an acute testing procedure.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Multistage low-energy stimulation Not Applicable

Detailed Description:
This is a research feasibility study to evaluate various parameters of the multistage low-energy pulses and their effect on atrial fibrillation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
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

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients indicated for an atrial fibrillation ablation procedure

Exclusion Criteria:

-

Contacts and Locations
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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


Locations
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France
Hôpital du Haut-Lévêque
Bordeaux, France
Sponsors and Collaborators
Cardialen, Inc.
More Information
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Publications:

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Responsible Party: Cardialen, Inc.
ClinicalTrials.gov Identifier: NCT02257112    
Other Study ID Numbers: CL001
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes