Atrial FibrillationSTARNCT04575662
Radiotherapy and Atrial Fibrillation
A study testing STAR Treatment in people with Atrial Fibrillation, run by Miulli General Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- STAR Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Linac Based STereotactic Arrhythmia Radioablation (STAR) of Atrial Fibrillation
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- STAR Treatment
- Keywords
- Atrial Fibrillation, Rhythm Control Strategy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR TreatmentRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| STAR Treatment | Experimental | Patients performing STAR treatment Receives: Radiation: STAR Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events related to STAR treatment
To estimate the cumulative proportion of patients' Adverse Events related to STAR treatment
Measured: Baseline through 12-months
Secondary outcomes (2)
Incidence of AF recurrence
To estimate the proportion of patients with AF
Measured: 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
Measured: Baseline through 10-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Jan 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- STAR treatment
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miulli General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Grimaldi, Miulli General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575662
- Sponsor's protocol ID
- MGH_002
- Acronym
- STAR
- Status last verified
- Aug 2022
- First submitted
- 29 Sep 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37988294Di 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.
PubMed 35649117Di 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.
PubMed 35310997
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linac Based STereotactic Arrhythmia Radioablation (STAR) of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04575662
- Acronym / sponsor ID
- STAR / MGH_002
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Rhythm Control Strategy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Miulli General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- STAR treatment
| Arm | Type | Receives |
|---|---|---|
| STAR Treatment | Experimental | Radiation: STAR TreatmentPatients performing STAR treatment |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAR TreatmentRadiation 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. | Radiation | STAR Treatment |
Primary outcome
Incidence of Adverse Events related to STAR treatment
Time frame: Baseline through 12-months
To estimate the cumulative proportion of patients' Adverse Events related to STAR treatment
2 secondary outcomes
Incidence of AF recurrence
Time frame: Baseline through 12-months
Long-term clinical outcomes
Time frame: Baseline through 10-years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Derived from this study: PubMed 37988294Di 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.
- Derived from this study: PubMed 35649117Di 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.
- Derived from this study: PubMed 35310997Di 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAR Treatment in people with Atrial Fibrillation, run by Miulli General Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events related to STAR treatment (time frame: Baseline through 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04575662, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.