Radiotherapy and Atrial Fibrillation (STAR)

August 8, 2022 updated by: Massimo Grimaldi, Miulli General Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bari
      • Acquaviva Delle Fonti, Bari, Italy, 70021
        • Miulli General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline through 12-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of AF recurrence
Time Frame: Baseline through 12-months
To estimate the proportion of patients with AF
Baseline through 12-months
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
Baseline through 10-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miulli General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGH_002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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