Pulmonary Vein Isolation Using Stereotactic Radiotherapy System for the Treatment of Refractory Atrial Fibrillation

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: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Radiation: Stereotactic Radiotherapy

Detailed Description

This is a single center, single arm, prospective and phase 1 clinical trial. Patients with refractory atrial fibrillation (AF) will receive single fraction stereotactic radiotherapy for pulmonary vein isolation. To minimize the potential risks associated with this innovative technique, the study has been designed in a stepwise dose escalation fashion under carefully observation by the investigators. The dose escalation is guided by 3+3 algorithm to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level than will be chosen as optimal dose of maximal effects. Low dosing levels with established safety profile will first be applied before administering higher dosing levels based on preclinical studies.

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 (for paroxysmal AF) or AF burden (for persistent AF) after 90 days of blank period until 12 months post-treatment.

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

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University
      • Contact: Yi-Gang Li, Dr.; Phone Number: 86 021 25077275; Email: liyigang@xinhuamed.com.cn
      • Principal Investigator: Yi-Gang Li, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Paroxysmal or persistent atrial fibrillation. Age 55-89 Symptomatic, refractory to at least 3 antiarrhythmic drugs Failure from the previous catheter ablation of atrial fibrillation, or contraindicate /unwilling to undergo catheter ablation.

Anticoagulation for at least 3 months if CHA2DS2-VASc 2 or more.

Exclusion Criteria:

With concomitant atrial flutter, WPW syndrome or supraventricular tachycardia. With sustained ventricular tachycardia. With sick sinus syndrome or atrioventricular block fulfilling the indication of permanent pacemaker implantation.

Stroke or myocardial infarction within 8 weeks. Uncontrolled heart failure or unstable angina pectoris. Severe structral heart diseases. Severe pulmonary hypertension. Uncontrolled hypertension. Severe respiratory disease. Esophageal ulcer. Intracardiac thrombus by TEE. Pregnancy or have a preganancy plan. Others.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stereotactic body radiotherapy (SBRT); Noninvasive SBRT will be delivered in a single fraction to electrical isolate the pulmonary veins under CT-guidance.	Radiation: Stereotactic Radiotherapy; Stereotactic radiotherapy targets on the pulmonary vein ostium aiming to achieve pulmonary vein electrial isolation

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 (for paroxysmal atrial fibrillation)	Recurrence of atrial fibrillation after 90 days blanking period post-treatment	90 days to 12 months
Atrial fibrillation burden reduction (for persistent atrial fibrillation)	Atrial fibriilation burden reduction after 90 days blanking period post-treatment	90 days to 12 months
All-cause motality	Motality due to any reason	12 months
Quality of life improvement	Quality of life after the procedure evaluated by the questionnaire	3 month, 6 month and 12 month

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Yi-Gang Li, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: XHEC-C-2019-047-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No