Stereotactic Radioablation for the Treatment of Refractory Atrial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04833712
Study type	Interventional
Source	National and Kapodistrian University of Athens
Contact	Spyridon Deftereos, MD, PhD
Phone	+30-2105832352
Email	spdeftereos@gmail.com
Status	Recruiting
Phase	N/A
Start date	May 10, 2021
Completion date	August 30, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms