Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02257112
• Other study ID #: CL001
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: June 30, 2016

Study information

• Verified date: August 2022
• Source: Cardialen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a research feasibility study to evaluate various parameters of the multistage low-energy pulses and their effect on atrial fibrillation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients indicated for an atrial fibrillation ablation procedure

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Multistage low-energy stimulation
The parameters of the Multistage waveform will be altered and the response of the atria will be recorded.

Locations

Country	Name	City	State
France	Hôpital du Haut-Lévêque	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Cardialen, Inc.

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Patients will be followed during the acute procedure which is expected to average 60 minutes