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

NCT04486339 | Unknown

• 1 other identifier: XHEC-C-2019-047-4
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 12 months adverse events by CTCA5

  12 months

• Recurrence of atrial fibrillation (for paroxysmal atrial fibrillation)

  90 days to 12 months

• Atrial fibrillation burden reduction (for persistent atrial fibrillation)

  90 days to 12 months

• All-cause motality

  12 months

• Quality of life improvement

  3 month, 6 month and 12 month

Study Arms (1)

stereotactic body radiotherapy (SBRT)

EXPERIMENTAL

Noninvasive SBRT will be delivered in a single fraction to electrical isolate the pulmonary veins under CT-guidance.

Radiation: Stereotactic Radiotherapy

Interventions

Stereotactic Radiotherapy RADIATION

Stereotactic radiotherapy targets on the pulmonary vein ostium aiming to achieve pulmonary vein electrial isolation

stereotactic body radiotherapy (SBRT)

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yi-Gang Li

  Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Gang Li

CONTACT

86-21-25077260; liyigang@xinhuamed.com.cn

Mu Chen

CONTACT

chenmu@xinhuamed.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 24, 2020
• Study Start: December 1, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2022
• Last Updated: July 24, 2020

Record last verified: 2019-12

Locations

CN (1)