Status:
COMPLETED
INtra-procedural ultraSound Imaging During Pulmonary Veins Isolation
Lead Sponsor:
Oxford University Hospitals NHS Trust
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
40-80 years
Brief Summary
One of the biggest limitations of the currently used percutaneous techniques for Pulmonary Vein Isolation (PVI) in the setting of atrial fibrillation ablation is the lack of real-time information abou...
Detailed Description
Patients scheduled for their first pulmonary vein (PV) isolation ablation for symptomatic, drug-refractory paroxysmal atrial fibrillation (AF), will be considered for inclusion in the study. Potentia...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Males older than 40 years or females older than 40 and sterile or in post-menopausal age;
- willing and able to give informed consent for participation in the study;
- history of symptomatic and drug-refractory paroxysmal atrial fibrillation (AF);
- planned AF ablation on a clinical basis.
- Exclusion Criteria
- age less than 40 years and more than 80 years;
- pregnancy, trying for a baby or breast feeding;
- any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study;
- documented allergy to iodinated contrast medium;
- renal insufficiency (eGFR\<30);
- weight exceeding the maximum load of the scanner (250kg).
Exclusion
Key Trial Info
Start Date :
November 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03372798
Start Date
November 1 2016
End Date
December 1 2017
Last Update
April 18 2024
Active Locations (1)
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1
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU