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TAES for FPVCs: a Pragmatic, Randomized Controlled Trial

RecruitingNAAges 18 Years - 75 YearsAllGuang'anmen Hospital of China Academy of Chinese โ€ฆ
NCT04415203 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

This prospective, randomized controlled trial aims to evaluate the efficacy and safety of Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS) for patients with frequent premature ventricular coomplexes (FPVCs). Ninety participants will be randomized to TAVNS group and sham-TAVNS group with the ratio of 1:1. They will receive TAVNS plus usual care or sham-TAVNS plus usual care for 6 weeks, and then be followed up for 12 weeks after the treatment. The primary outcome was the proportion of participants with a 50% decrease of the 24 hour (24h) premature ventricular complexes (PVCs) after 6-week treatment. Secondary outcomes include the proportion of participants with a 75% decrease of the 24h-PVCs; the decrease from baseline of 24h-PVCs, total 24h-heartbeat, and the frequency of supraventricular arrhythmia; the score change from baseline in PVCs-related symptoms; the score change from b

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosed as frequent premature ventricular contractions; * 2 โ‰ค Lown level โ‰ค 4A; * 18 โ‰ค age โ‰ค 75; * Volunteered to participant Exclusion Criteria: * Severe valvular disease, congenital heart disease, pericardial disease, hypertrophic cardiomyopathy, unstable angina pectoris, acute myocardial infarction, myocarditis, aneurysm, congestive heart failure decompensation period (NYHA grade III or VI), cardiogenic shock, cerebrovascular disease, hematopoietic system disease, severe mental disease; * Bradycardia, including pathologic sinus node syndrome, degree II or greater atrioventricular block; * Those who have already had pacemaker or percutaneous coronary intervention, or who plan to have pacemaker or percutaneous coronary intervention; * Pregnant or lactating women; * Local sensory deficit, or allergic to current; * May be allergic to percutaneous patches๏ผ› * Blood pressure โ‰ค 90/60 mmHg; * Those who have participated in other clinical trials within 3 months.
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What it tests

  • Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS)
  • Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS)
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Where

1 site
Guang'anmen Hospita, China Academy of Chinese Medical Sciences
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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