Status:
UNKNOWN
Non-fluoroscopy Ablation of AF/AT
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Collaborating Sponsors:
Baylis Medical Company
Conditions:
AF - Atrial Fibrillation
Atrial Tachycardia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Atrial fibrillation is the most common arrhythmia but can be treated by a catheter procedure where specialized wires (so-called catheters) are inserted in the left upper heart chamber. This requires c...
Detailed Description
The hypothesis is that patients who undergo one or more TSP(s) for atrial fibrillation or left atrial tachycardia can be studied without the use of fluoroscopy which should result in a low or ZERO ove...
Eligibility Criteria
Inclusion
- Any type of atrial fibrillation or left atrial tachycardia
- Able to give written informed consent
- Age \>18 years old and ≤ 80 years
- Fulfill established clinical criteria for catheter ablation of atrial fibrillation (1)
- No evidence of significant structural heart disease or congenital heart disease
Exclusion
- Intolerance or unwillingness to oral anticoagulation with Warfarin
- Bleeding disorder
- Contraindication to CT scan
- Presence of intracardiac thrombus
- Vascular disorder preventing access to femoral veins
- Cardiac congenital abnormality
- Severe, life threatening non-cardiac disease
- Active malignant disease and recent (\<5 years) malignant disease
- Presence of ASD or PFO closure device
- Unable or unwilling to comply with F/U requirements
- Renal impairment
- Pregnancy
Key Trial Info
Start Date :
October 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 8 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03750435
Start Date
October 8 2018
End Date
October 8 2019
Last Update
November 26 2018
Active Locations (1)
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1
Royal Brompton and Harefield NHS Foundation Trust
London, United Kingdom, SW3 6NP