Clinical trial NCT04575662: Radiotherapy and Atrial Fibrillation
Official title: Linac Based STereotactic Arrhythmia Radioablation (STAR) of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Rhythm Control Strategy
Lead sponsor: Miulli General Hospital
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 20
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: STAR treatment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events related to STAR treatment
timeFrame: Baseline through 12-months
Secondary outcomes:
measure: Incidence of AF recurrence
timeFrame: Baseline through 12-months
measure: Long-term clinical outcomes
timeFrame: Baseline through 10-years
Other outcomes:
Locations:
city: Acquaviva Delle Fonti
country: Italy
facility: Miulli General Hospital
state: Bari
Study officials:
References:
citation: Di Monaco A, Gregucci F, Bonaparte I, Troisi F, Surgo A, Di Molfetta D, Vitulano N, Quadrini F, Carbonara R, Ludovico E, Ciliberti MP, Fiorentino A, Grimaldi M. First Pulmonary Vein Isolation Using LINAC-Based STAR. Circ Arrhythm Electrophysiol. 2022 Jun;15(6):e010880. doi: 10.1161/CIRCEP.122.010880. Epub 2022 Jun 1. No abstract available.
citation: Di Monaco A, Gregucci F, Bonaparte I, Troisi F, Surgo A, Di Molfetta D, Vitulano N, Quadrini F, Carbonara R, Martinelli G, Guida P, Ciliberti MP, Fiorentino A, Grimaldi M. Paroxysmal Atrial Fibrillation in Elderly: Worldwide Preliminary Data of LINAC-Based Stereotactic Arrhythmia Radioablation Prospective Phase II Trial. Front Cardiovasc Med. 2022 Mar 2;9:832446. doi: 10.3389/fcvm.2022.832446. eCollection 2022.