Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02257112
• Lead Sponsor: Cardialen, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-09-24
• Study First Submitted QC: 2014-10-02
• Study First Posted: 2014-10-06
• Primary Completion: 2016-06-30
• Study Completion: 2016-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• patients indicated for an atrial fibrillation ablation procedure

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hôpital du Haut-Lévêque; 🇫🇷 Bordeaux, France