Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-01-01
2023-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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STAR Treatment
Patients performing STAR treatment
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
70 Years
ALL
No
Sponsors
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Miulli General Hospital
OTHER
Responsible Party
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Massimo Grimaldi
Head of Arrhythmology and Electrophysiology Unit
Locations
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Miulli General Hospital
Acquaviva delle Fonti, Bari, Italy
Countries
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References
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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.
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.
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.
Other Identifiers
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MGH_002
Identifier Type: -
Identifier Source: org_study_id
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