Permanent Atrial Fibrillation
Conditions
Keywords
Electrophysiological mapping, Multi-electrode catheter
Brief summary
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.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Record 20 sets of electrophysiological data with a multi-electrode mapping catheter. | Acute - time of procedure |
Countries
Czechia, United Kingdom
Outcome results
None listed