Radiotherapy and Atrial Fibrillation

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    20
  • sponsor
    Miulli General Hospital
Updated on 12 April 2021

Summary

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. Current European guidelines recommend catheter ablation of AF in symptomatic patients refractory to antiarrhythmic therapy. Pulmonary vein isolation (PVI) remains the cornerstone of any ablation procedure irrespective of patient characteristics. Recently, stereotactic arrhythmia radioablation (STAR) with precise high-dose of radiation was used to treat ventricular arrhythmias in patients with a high risk of complications during transcatheter ablation.

Description

Exploratory study to investigate the feasibility of STAR for the treatment of paroxysmal AF in elderly patients in which a rhythm control strategy is indicated. Patients will be followed-up for 12 months after STAR treatment for a safety assessment and AF recurrence.

Details
Condition Arrhythmia, Dysrhythmia, Arrhythmia, Atrial Fibrillation, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Atrial Fibrillation (Pediatric), Dysrhythmia
Treatment STAR Treatment
Clinical Study IdentifierNCT04575662
SponsorMiulli General Hospital
Last Modified on12 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age > 70 years
Symptomatic Paroxysmal AF
Antiarrhythmic drugs intolerance or non-response to antiarrhythmic drugs
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
Expected to remain available for at least 24 months after enrollment

Exclusion Criteria

Permanent AF
Need or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
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
Left atrial thrombus (e.g., transesophageal echocardiogram (TEE), CT and ICE)
History of a documented thromboembolic event such as stroke or transient ischemic neurological attack (TIA) in the three months prior to enrollment
Currently enrolled in another trial that has not completed the required follow-up period and would conflict with this study
Any other clinical condition that might jeopardize patient safety during participation in this trial or prevent the subject from adhering to the trialprotocol
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