patent foramen ovale
Conditions
Interventions
case group:wenxin keli 9g 3times a day
control group:placebo 9g 3times a day
Sponsors
First Affiliated Hospital, Xi’an Jiaotong University
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: 1)Patients =16 years who had a definite diagnosis of patent foramen ovale and were expected to undergo closure;Diagnosis of PFO was established when right to left shunt was observed during contrast transthoracic echocardiography or contrast enhanced transcranial Doppler with and without a Valsalva maneuver; 2)After multidisciplinary evaluation by the Department of Neurology and the Department of structural cardiology, PFO-related embolism or ischemic events were considered, including transient ischemic attack, stroke, peripheral embolism, migraine, orthostatic hypoxia syndrome, etc., and PFO closure was required to prevent recurrence. 3)High risk factors for postoperative arrhythmia (male sex, age =60 years, left occludable umbrella disc =25mm, previous ECG monitoring found supraventricular ectopic activity
Exclusion criteria
Exclusion criteria: < 16 years of age; A clear cause of other embolic events; Patients who are allergic to rubber or electrodes; A history of atrial fibrillation, atrial flutter and supraventricular tachycardia; Severe valvular disease, other congenital heart diseases, cardiomyopathy, acute coronary syndrome, heart failure (NYHA III or IV); Blood system disease unable to tolerate anticoagulant antiplatelet therapy; More than 2 times the upper limit of normal of elevation of transaminase and urea nitrogen ; Pregnancy and lactation women; Thyroid disease; Participating in other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of new onset of AF, supraventricular tachycardia, or atrial flutter lasting >30 seconds; | — |
Secondary
| Measure | Time frame |
|---|---|
| arrhythmia related symptom scores;Atrial premature contraction burden;Ventricular premature contraction burden;Ventricular tachycardia; | — |
Countries
China
Contacts
Public ContactYushun Zhang
Department of Structural Heart Disease, First Affiliated Hospital, Xi’an Jiaotong University
Outcome results
None listed