Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation

NCT ID: NCT02257112

Last Updated: 2022-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-06-30

Brief Summary

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

Detailed Description

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

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Multistage low-energy stimulation

Intervention Type DEVICE

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

Interventions

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Multistage low-energy stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients indicated for an atrial fibrillation ablation procedure

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardialen, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital du Haut-Lévêque

Bordeaux, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 24076284 (View on PubMed)

Other Identifiers

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CL001

Identifier Type: -

Identifier Source: org_study_id

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