Radiotherapy and Atrial Fibrillation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Linac Based STereotactic Arrhythmia Radioablation (STAR) of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Radiation: STAR Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: STAR treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STAR Treatment<br>Patients performing STAR treatment | Radiation: STAR Treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events related to STAR treatment | To estimate the cumulative proportion of patients' Adverse Events related to STAR treatment | Baseline through 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AF recurrence | To estimate the proportion of patients with AF | Baseline through 12-months | 
| Long-term clinical outcomes | To estimate the cumulative proportion of all-cause death, cardiovascular death, stroke, heart failure hospitalization, AF recurrence, cancer occurrence | Baseline through 10-years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Rhythm Control Strategy