Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STAR Treatment | Experimental | Patients performing STAR treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STAR Treatment | Radiation | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miulli General Hospital | Acquaviva delle Fonti | Bari | 70021 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37988294 | Derived | Di Monaco A, Gregucci F, Bonaparte I, Romanazzi I, Troisi F, Surgo A, Vitulano N, Quadrini F, Valenti N, Carbonara R, Di Guglielmo FC, Ludovico E, Calbi R, Guida P, Ciliberti MP, Fiorentino A, Grimaldi M. Linear accelerator-based stereotactic arrhythmia radioablation for paroxysmal atrial fibrillation in elderly: a prospective phase II trial. Europace. 2023 Dec 6;25(12):euad344. doi: 10.1093/europace/euad344. | |
| 35649117 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
STAR treatment
Not provided
Not provided
Not provided
Not provided
| Baseline through 10-years |
| Derived |
| 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. |
| 35310997 | Derived | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |