Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation

NCT02257112 | Completed

• 1 other identifier: CL001
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (1)

Multistage low-energy stimulation

EXPERIMENTAL

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

Interventions

Multistage low-energy stimulation DEVICE

The parameters of the Multistage waveform will be altered and the response of the atria will be recorded.

Multistage low-energy stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients indicated for an atrial fibrillation ablation procedure

Sponsors & Collaborators

• Cardialen, Inc.: lead

Study Sites (1)

Hôpital du Haut-Lévêque

Bordeaux, France

Location

Related 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.

  PMID: 24076284 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: October 6, 2014
• Study Start: April 1, 2014
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)