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Radiotherapy and Atrial Fibrillation (STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04575662
Recruitment Status : Active, not recruiting
First Posted : October 5, 2020
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
Massimo Grimaldi, Miulli General Hospital

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Radiation: STAR Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: STAR treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Linac Based STereotactic Arrhythmia Radioablation (STAR) of Atrial Fibrillation
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: STAR Treatment
Patients performing STAR treatment
Radiation: 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of AF recurrence [ Time Frame: Baseline through 12-months ]
    To estimate the proportion of patients with AF

  2. Long-term clinical outcomes [ Time Frame: Baseline through 10-years ]
    To estimate the cumulative proportion of all-cause death, cardiovascular death, stroke, heart failure hospitalization, AF recurrence, cancer occurrence



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 70 years
  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:

  1. Permanent AF
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04575662


Locations
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Italy
Miulli General Hospital
Acquaviva Delle Fonti, Bari, Italy, 70021
Sponsors and Collaborators
Miulli General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Massimo Grimaldi, Head of Arrhythmology and Electrophysiology Unit, Miulli General Hospital
ClinicalTrials.gov Identifier: NCT04575662    
Other Study ID Numbers: MGH_002
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Massimo Grimaldi, Miulli General Hospital:
Atrial Fibrillation
Rhythm Control Strategy
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes