Prevention of arrhythmia after patent foramen ovale closure with Wenxin granules: a single-center, double-blind, randomized controlled trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: case group:wenxin keli 9g 3times a day;control group:placebo 9g 3times a day; CONDITION: patent foramen ovale PRIMARY OUTCOME: the incidence of new onset of AF, supraventricular tachycardia, or atrial flutter lasting >30 seconds; SECONDARY OUTCOME: arrhythmia related symptom scores;Atrial premature contraction burden;Ventricular premature contraction burden;Ventricular tachycardia; 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
Epistemonikos ID: adf30e313bf5b9b7f59f92926e30a89bf50cca30
First added on: Feb 20, 2024