Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment
Completed
- Conditions
- Permanent Atrial Fibrillation
- Registration Number
- NCT01765075
- Lead Sponsor
- Boston Scientific Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Record 20 sets of electrophysiological data with a multi-electrode mapping catheter. Acute - time of procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Na Homolce
🇨🇿Prague, Czech Republic
Guys & St. Thomas' Hospital
🇬🇧London, United Kingdom