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Clinical Trials/NCT02257112
NCT02257112
Completed
Not Applicable

Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation

Cardialen, Inc.1 site in 1 country47 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Cardialen, Inc.
Enrollment
47
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
June 30, 2016
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients indicated for an atrial fibrillation ablation procedure

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Study Sites (1)

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