184
Participants
Start Date
April 5, 2023
Primary Completion Date
December 30, 2024
Study Completion Date
December 30, 2024
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.
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 If intolerable symptoms persisted despite dose reductions, the drug will be withdrawn, and the patient was released from the study.
RECRUITING
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing
Beijing Chao Yang Hospital
OTHER
RenJi Hospital
OTHER
Yeditepe University Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Ningbo No. 1 Hospital
OTHER
Fuwai Yunnan Cardiovascular Hospital
OTHER
Henan Provincial People's Hospital
OTHER
China National Center for Cardiovascular Diseases
OTHER_GOV