Treatment Strategy of Vasovagal Syncope

NARecruitingINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

April 5, 2023

Primary Completion Date

December 30, 2024

Study Completion Date

December 30, 2024

Conditions
Syncope, Vasovagal
Interventions
PROCEDURE

Cardioneuroablation

The left atrium model was established under the guidance of three-dimensional mapping. Atrial septum puncture、left atrium mapping and right atrium mapping will be performed according to standard EP lab protocol. The location of GPs will be detected with HAFE potential (duration ≥ 50ms, deflections ≥ 4 times, amplitude ≥ 0.7mV) and high frequency stimulation (HFS; 30 Hz, 20 mV, pulse width 2ms) through positive vasovagal response (transient ventricular asystole, atrioventricular block, or R-R interval increased by 30%) . Saline Irrigated-tip catheter with pressure monitoring will be applied for the procedure, and radiofrequency energy is limited to 40W and 43℃ for at least 30s at each site. The ablation endpoint for each GP is defined as the complete elimination of all targeted HAFE potential and elimination of positive vasovagal response. The endpoint of the procedure was that the heart rate reach 75% of the maximum heart rate in atropine test.

DRUG

Midodrine Oral Tablet

Midodrine will start dosing with 5 mg of the study drug 3 times daily, 4 hours apart, during daylight hours.Dose with be adjusted within a range of 2.5 mg twice daily, 4 hours apart, up to 10 mg, 3 times daily, every 4 hours. The optimal dose ranging be completed within the first 2 weeks. If intolerable symptoms persisted despite dose reductions, the drug will be withdrawn, and the patient was released from the study.

Trial Locations (1)

Unknown

RECRUITING

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing

All Listed Sponsors
collaborator

Beijing Chao Yang Hospital

OTHER

collaborator

RenJi Hospital

OTHER

collaborator

Yeditepe University Hospital

OTHER

collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

collaborator

Ningbo No. 1 Hospital

OTHER

collaborator

Fuwai Yunnan Cardiovascular Hospital

OTHER

collaborator

Henan Provincial People's Hospital

OTHER

lead

China National Center for Cardiovascular Diseases

OTHER_GOV