Status:
UNKNOWN
Stereotactic Radioablation for the Treatment of Refractory Atrial Fibrillation
Lead Sponsor:
National and Kapodistrian University of Athens
Collaborating Sponsors:
Medtronic
Conditions:
Atrial Fibrillation
Arrythmia
Eligibility:
All Genders
65-89 years
Phase:
NA
Brief Summary
The study aims to investigate the short-term (3 months) and intermediate-term (12 months) safety and preliminary efficacy of stereotactic radiotherapy for pulmonary vein isolation to treat refractory ...
Detailed Description
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. Current guidelines recommend catheter ablation of AF in symptomatic patients refractory to antiarrhythmic therapy. Pulmonary v...
Eligibility Criteria
Inclusion
- Age 65-89
- Paroxysmal or persistent symptomatic AF refractory to antiarrhythmic drugs.
- Failure from the previous catheter ablation of AF, or contraindicate /unwilling to undergo catheter ablation.
- Dual chamber pacemaker implanted
- Understands the nature of the study, treatment procedure and provides written informed consent
- Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements
Exclusion
- Permanent AF
- Unstable angina
- Presence of any disease that is likely to shorten life expectancy to \< 1 year
- Any cardiac surgery within three months prior to enrolment
- Awaiting cardiac transplantation or other cardiac surgery within the next year
- Myocardial infarction (MI) within 60 days prior to enrolment
- Contraindications to oral anticoagulation
- Active systemic infection or sepsis
- History of a documented thromboembolic event such as stroke or transient ischemic neurological attack (TIA) in the three months prior to enrollment.
- Any other clinical condition that might jeopardize patient safety during participation in this trial or prevent the subject from adhering to the trialprotocol
- Esophageal ulcer.
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04833712
Start Date
May 10 2021
End Date
August 30 2022
Last Update
April 6 2021
Active Locations (2)
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1
Attikon University Hospital
Chaïdári, Greece
2
Mediterraneo Hospital
Glyfada, Greece