Radiotherapy and Atrial Fibrillation

NCT04575662 | Unknown

• 1 other identifier: MGH_002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Rhythm Control Strategy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of AF recurrence

  Baseline through 12-months

• Long-term clinical outcomes

  Baseline through 10-years

Study Arms (1)

STAR Treatment

EXPERIMENTAL

Patients performing STAR treatment

Radiation: STAR Treatment

Interventions

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.

STAR Treatment

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Miulli General Hospital: lead

Study Sites (1)

Miulli General Hospital

Acquaviva delle Fonti, Bari, 70021, Italy

Location

Related Publications (3)

• 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.

  PMID: 37988294 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.

  PMID: 35649117 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.

  PMID: 35310997 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Arrhythmology and Electrophysiology Unit

Model Details: STAR treatment

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)