NCT04415203 TAES for FPVCs: a Pragmatic, Randomized Controlled Trial
| NCT ID | NCT04415203 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
| Condition | Premature Ventricular Complexes |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2020-06-04 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2020-06-04 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 baseline in SAS and SDS. Subgroup analyses will be performed in age, gender, and the severity of PVCs. Safety assessment will be documented during the whole trial.
Eligibility Criteria
Inclusion Criteria: * Diagnosed as frequent premature ventricular contractions; * 2 ≤ Lown level ≤ 4A; * 18 ≤ age ≤ 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； * Blood pressure ≤ 90/60 mmHg; * Those who have participated in other clinical trials within 3 months.
Contact & Investigator
Jiani Wu
PRINCIPAL INVESTIGATOR
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Frequently Asked Questions
Who can join the NCT04415203 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Premature Ventricular Complexes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04415203 currently recruiting?
Yes, NCT04415203 is actively recruiting participants. Contact the research team at jiani_wu@aliyun.com for enrollment information.
Where is the NCT04415203 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04415203 clinical trial?
NCT04415203 is sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. The principal investigator is Jiani Wu at Guang'anmen Hospital of China Academy of Chinese Medical Sciences. The trial plans to enroll 90 participants.