Stereotactic Radioablation for the Treatment of Refractory Atrial Fibrillation (RAD-AF)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Atrial Fibrillation; Arrythmia; Heart Arrhythmia
• Intervention / Treatment: Radiation: Stereotactic Radioablation

Detailed Description

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. Current 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, single fraction stereotactic radioablation has been used in patients with ventricular arrhythmias non-eligible for transcatheter ablation or after a failed transcatheter ablation.

This is a single center, single arm, prospective and phase 1 clinical trial. Patients with refractory AF non-eligible for transcatheter ablation or after a failed transcatheter ablation will receive stereotactic radioablation for PVI.

The target contours for paroxysmal AF stereotactic radioablation will cover the left atrial-venous wall, the myocardium and the myocardial sleeves of the PVs transmural at the PV antrum, similar to catheter ablation. The contours will be approximately 4-6 mm wide along the PVs / LA and approximately 2-4 mm deep depending on the tissue thickness.

A pre-validation study will evaluate the location with respect to right and left PVs. Patients with esophagus in direct contact with the actual target lesion will be excluded.

PVI will be assessed by means of Cardio Insight non invasive mapping system during radioablation.

Safety is the primary endpoint of the study. Safety will be assessed by incidence and evaluation of any serious adverse evens using CTCAE V5.0 criteria associated with the procedure through 90 days (short-term) and 12 months (intermediate term).

Efficacy will be evaluated by assessing atrial fibrillation recurrence and AF burden after 90 days of blank period until 12 months post-treatment based on pacemaker interrogation.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Spyridon Deftereos, MD, PhD; Phone Number: +30-2105832352; Email: spdeftereos@gmail.com

Study Locations

• Greece
  • Chaïdári, Greece
    • Recruiting
    • Attikon University Hospital
    • Contact: Spyridon Deftereos, MD, PhD; Email: spdeftereos@gmail.com
    • Principal Investigator: Spyridon Deftereos, MD, PhD
    • Principal Investigator: Vasilios Kouloulias, MD, PhD
  • Glyfáda, Greece
    • Recruiting
    • Mediterraneo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 89 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Stereotactic Radioablation; 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; Stereotactic Radioablation targets on the pulmonary vein ostium aiming to achieve PVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
12 months 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	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

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 10, 2021
• Primary Completion (ANTICIPATED): August 30, 2021
• Study Completion (ANTICIPATED): August 30, 2022

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (ACTUAL): April 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 2, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: AF
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: 517/17.9.2020

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