Radiotherapy and Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— STAR  

Official title:

Linac Based STereotactic Arrhythmia Radioablation (STAR) of Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04575662
• Other study ID #: MGH_002
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: August 2022
• Source: Miulli General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Radiation:
• STAR 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.

Locations

Country	Name	City	State
Italy	Miulli General Hospital	Acquaviva Delle Fonti	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Miulli General Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of AF recurrence	To estimate the proportion of patients with AF	Baseline through 12-months
Secondary	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