Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Rhythm Control Strategy
Brief 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.
Detailed 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.
Interventions
RADIATIONSTAR Treatment
Radiation therapy that delivers non-invasive, image-guided, precise high-dose of radiation to targets reducing dose exposure to adjacent normal tissue and minimizing the treatment toxicity.
Sponsors
Miulli General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
STAR treatment
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 70 years 2. Symptomatic Paroxysmal AF 3. Antiarrhythmic drugs intolerance or non-response to antiarrhythmic drugs 4. Understands the nature of the study, treatment procedure and provides written informed consent 5. Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements 6. Expected to remain available for at least 24 months after enrollment
Exclusion criteria
1. Permanent AF 2. Need or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial 3. Unstable angina 4. Presence of any disease that is likely to shorten life expectancy to \< 1 year 5. Any cardiac surgery within three months prior to enrolment 6. Awaiting cardiac transplantation or other cardiac surgery within the next year 7. Myocardial infarction (MI) within 60 days prior to enrolment 8. Contraindications to oral anticoagulation 9. Active systemic infection or sepsis 10. Left atrial thrombus (e.g., transesophageal echocardiogram (TEE), CT and ICE) 11. History of a documented thromboembolic event such as stroke or transient ischemic neurological attack (TIA) in the three months prior to enrollment. 12. Currently enrolled in another trial that has not completed the required follow-up period and would conflict with this study. 13. Any other clinical condition that might jeopardize patient safety during participation in this trial or prevent the subject from adhering to the trialprotocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events related to STAR treatment | Baseline through 12-months | To estimate the cumulative proportion of patients' Adverse Events related to STAR treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AF recurrence | Baseline through 12-months | To estimate the proportion of patients with AF |
| Long-term clinical outcomes | Baseline through 10-years | To estimate the cumulative proportion of all-cause death, cardiovascular death, stroke, heart failure hospitalization, AF recurrence, cancer occurrence |
Countries
Italy
Outcome results
None listed