Clinical trial NCT04486339: Pulmonary Vein Isolation Using Stereotactic Radiotherapy System for the Treatment of Refractory Atrial Fibrillation
Official title: Pulmonary Vein Isolation Using Stereotactic Radiotherapy System for the Treatment of Refractory Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 15
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 90 days adverse events by CTCA5
timeFrame: 90 days
Secondary outcomes:
measure: 12 months adverse events by CTCA5
timeFrame: 12 months
measure: Recurrence of atrial fibrillation (for paroxysmal atrial fibrillation)
timeFrame: 90 days to 12 months
measure: Atrial fibrillation burden reduction (for persistent atrial fibrillation)
timeFrame: 90 days to 12 months
measure: All-cause motality
timeFrame: 12 months
measure: Quality of life improvement
timeFrame: 3 month, 6 month and 12 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University
name: Yi-Gang Li
role: PRINCIPAL_INVESTIGATOR
References: