Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment

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

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-02-28

Brief Summary

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The purpose of the study is to gather electrophysiological data using a multi-electrode mapping catheter during a clinically indicated cardiac ablation procedure for the treatment of persistent atrial fibrillation.

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Detailed Description

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Conditions

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Permanent Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients undergoing cardiac ablation for permanent AF

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law
* Scheduled for a clinically indicated cardiac ablation for the treatment of persistent atrial fibrillation
* Able to meet study requirements for follow-up visit

Exclusion Criteria

* Permanent leads or presence of prosthetic or severely stenotic tricuspid or mitral valves
* Active systemic infection or sepsis
* Echocardiographically confirmed presence of thrombus
* Atrial thrombus, myxoma, inter-atrial baffle patch or occluder device for those subjects in whom a transseptal approach is required
* Subjects who cannot be anticoagulated or infused with heparinized saline
* Heparin induced thrombocytopenia
* Hemodynamic instability or shock
* Atrial anatomy contradictory to catheter labeling or size indices
* EF \< 35%
* Subjects with an active heart failure decompensation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No