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Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT02257112
Recruitment Status : Active, not recruiting
First Posted : October 6, 2014
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Cardialen, Inc.

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 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 : February 5, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


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.




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.



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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:


Information from the National Library of Medicine

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
France
Hôpital du Haut-Lévêque
Bordeaux, France
Sponsors and Collaborators
Cardialen, Inc.

Publications:
Responsible Party: Cardialen, Inc.
ClinicalTrials.gov Identifier: NCT02257112     History of Changes
Other Study ID Numbers: CL001
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes