Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation

• Sponsor: Cardialen, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02257112
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arm: 1
• Duration (Months): 27
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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: Apr 1, 2014
• Actual Primary Completion Date: Jun 30, 2016
• Actual Study Completion Date: Jun 30, 2016

Arms and Interventions

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

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. [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

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients indicated for an atrial fibrillation ablation procedure

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital du Haut-Lévêque	Bordeaux		France

Sponsors and Collaborators

• Cardialen, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Cardialen, Inc.
• ClinicalTrials.gov Identifier: NCT02257112
• Other Study ID Numbers: CL001
• First Posted: Oct 6, 2014
• Last Update Posted: Aug 12, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Aug 12, 2022