Stereotactic Radioablation for the Treatment of Refractory Atrial Fibrillation

NCT04833712 | Unknown

• 1 other identifier: 517/17.9.2020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

The study aims to investigate the short-term (3 months) and intermediate-term (12 months) safety and preliminary efficacy of stereotactic radiotherapy for pulmonary vein isolation to treat refractory atrial fibrillation.

Conditions

Atrial Fibrillation; Arrythmia; Cardiovascular Diseases; Heart Arrhythmia

Keywords

AF

Outcome Measures

Primary Outcomes (1)

• 90 days adverse events by CTCA5

  Safety will be assessed by incidence and evaluation of any adverse events using CTCA5 V5.0 criteria that are related to the procedure

  90 days

Secondary Outcomes (5)

• 12 months adverse events by CTCA5

  12 months

• Recurrence of atrial fibrillation after 90 days blanking period post-treatment

  90 days

• Atrial fibrillation burden reduction after 90 days blanking period post-treatment

  90 days to 12 months

• Cardiovascular Mortality

  12 months

• All-Cause Mortality

  12 months

Study Arms (1)

Stereotactic Radioablation

EXPERIMENTAL

Noninvasive Stereotactic Radioablation will be delivered in a single fraction to electrical isolate the pulmonary veins under CT-guidance. Pulmonary vein isolation will be assessed by using Cardioinsight non-invasive mapping system

Radiation: Stereotactic Radioablation

Interventions

Stereotactic Radioablation RADIATION

Stereotactic Radioablation targets on the pulmonary vein ostium aiming to achieve PVI

Stereotactic Radioablation

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65-89
• Paroxysmal or persistent symptomatic AF refractory to antiarrhythmic drugs.
• Failure from the previous catheter ablation of AF, or contraindicate /unwilling to undergo catheter ablation.
• Dual chamber pacemaker implanted
• 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

You may not qualify if:

• Permanent AF
• 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
• History of a documented thromboembolic event such as stroke or transient ischemic neurological attack (TIA) in the three months prior to enrollment.
• Any other clinical condition that might jeopardize patient safety during participation in this trial or prevent the subject from adhering to the trialprotocol
• Esophageal ulcer.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Medtronic: collaborator

Study Sites (2)

Attikon University Hospital

Chaïdári, Greece

RECRUITING

Mediterraneo Hospital

Glyfada, Greece

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Spyridon Deftereos, MD, PhD

CONTACT

+30-2105832352; spdeftereos@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 6, 2021
• Study Start: May 10, 2021
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2022
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)