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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04486339
• Other study ID #: XHEC-C-2019-047-4
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2019
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Yi-Gang Li
• Phone: 86-21-25077260
• Email: liyigang[@]xinhuamed.com.cn
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Radiation:
• Stereotactic Radiotherapy
Stereotactic radiotherapy targets on the pulmonary vein ostium aiming to achieve pulmonary vein electrial isolation

Locations

Country	Name	City	State
China	Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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