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OpenTrials
Completed

NCT Number: NCT02257112

Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital du Haut-Lévêque

Bordeaux, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients indicated for an atrial fibrillation ablation procedure

Exclusion criteria

-

Treatment and study plan

Multistage low-energy stimulation

Device

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

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.

    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.

Sponsors and collaborators

Lead sponsor

Cardialen, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 6, 2014
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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