Stereotactic Radioablation for the Treatment of Refractory Atrial Fibrillation

National and Kapodistrian University of Athens15 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation Arrythmia Cardiovascular Diseases Heart Arrhythmia

Interventions

Stereotactic RadioablationRADIATION

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

Eligibility

Sex: ALLMin age: 65 YearsMax age: 89 Years

Medical Language ↔ Plain English

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.

Locations (2)

Attikon University Hospital

Chaïdári, Greece

RECRUITING

Mediterraneo Hospital

Glyfada, Greece

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 90 days

Secondary Outcomes

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

Time frame: 12 months

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

Time frame: 90 days

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

Time frame: 90 days to 12 months

Cardiovascular Mortality

Time frame: 12 months

All-Cause Mortality

Time frame: 12 months

Central Contacts

Spyridon Deftereos, MD, PhD

CONTACT

+30-2105832352 spdeftereos@gmail.com

Data from ClinicalTrials.gov

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