Status:
COMPLETED
Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Medtronic
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This is a multi-site, randomized, investigator-initiated pilot study to evaluate the efficacy of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of radio opaque ...
Detailed Description
Surgical and catheter based technologies target triggers that initiate atrial fibrillation located in the pulmonary veins (PV). In order to isolate these triggers, radiofrequency energy or freezing is...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Paroxysmal atrial fibrillation refractory to treatment with anti-arrhythmic drugs
- Must be able to undergo pre-operative cardiac CT angiogram or cardiac MRI to define pulmonary vein anatomy.
- Exclusion criteria:
- Planned use of radiofrequency cardiac ablation
- Presence of a cardiac implantable electronic device
- Conditions where manipulation of the catheter would be unsafe such as intracardiac thrombus
- Patients with active systemic infections
- Patients with cryoglobulinemia
- Pregnant and/or breast-feeding females are excluded from this study.
Exclusion
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2016
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03786822
Start Date
June 1 2015
End Date
December 20 2016
Last Update
December 26 2018
Active Locations (1)
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1
University of Texas Southwestern
Dallas, Texas, United States, 75390