Back to resultsRadiotherapy and Atrial Fibrillation (STAR)
Primary Purpose
Atrial Fibrillation
Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
STAR Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Rhythm Control Strategy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Miulli General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
STAR Treatment
Arm Description
Patients performing STAR treatment
Outcomes
Primary Outcome Measures
Incidence of Adverse Events related to STAR treatment
To estimate the cumulative proportion of patients' Adverse Events related to STAR treatment
Secondary Outcome Measures
Incidence of AF recurrence
To estimate the proportion of patients with AF
Long-term clinical outcomes
To estimate the cumulative proportion of all-cause death, cardiovascular death, stroke, heart failure hospitalization, AF recurrence, cancer occurrence
Full Information
NCT ID
NCT04575662
First Posted
September 29, 2020
Last Updated
August 8, 2022
Sponsor
Miulli General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04575662
Brief Title
Radiotherapy and Atrial Fibrillation
Acronym
STAR
Official Title
Linac Based STereotactic Arrhythmia Radioablation (STAR) of Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Miulli General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Rhythm Control Strategy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
STAR treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STAR Treatment
Arm Type
Experimental
Arm Description
Patients performing STAR treatment
Intervention Type
Radiation
Intervention Name(s)
STAR Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Adverse Events related to STAR treatment
Description
To estimate the cumulative proportion of patients' Adverse Events related to STAR treatment
Time Frame
Baseline through 12-months
Secondary Outcome Measure Information:
Title
Incidence of AF recurrence
Description
To estimate the proportion of patients with AF
Time Frame
Baseline through 12-months
Title
Long-term clinical outcomes
Description
To estimate the cumulative proportion of all-cause death, cardiovascular death, stroke, heart failure hospitalization, AF recurrence, cancer occurrence
Time Frame
Baseline through 10-years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Miulli General Hospital
City
Acquaviva Delle Fonti
State/Province
Bari
ZIP/Postal Code
70021
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35649117
Citation
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.
Results Reference
derived
PubMed Identifier
35310997
Citation
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.
Results Reference
derived
Learn more about this trial
Radiotherapy and Atrial Fibrillation
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