Radiotherapy and Atrial Fibrillation

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Radiation: STAR Treatment

• Registration Number: NCT04575662
• Lead Sponsor: Miulli General Hospital

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.

Study Timeline

• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-05
• Study Start: 2021-01-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STAR Treatment	STAR Treatment	Patients performing STAR treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Miulli General Hospital; 🇮🇹 Acquaviva Delle Fonti, Bari, Italy