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A prospective multicenter clinical study on the treatment of paroxysmal atrial fibrillation with Traditional Chinese Medicine (TCM) based on real-world evidence.

A prospective multicenter clinical study on the treatment of paroxysmal atrial fibrillation with Traditional Chinese Medicine (TCM) based on real-world evidence.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026001613
Enrollment
Unknown
Registered
2026-06-26
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation

Interventions

Exposure group:Receiving TCM treatment
Non-exposure group:Not receiving TCM treatment

Sponsors

Jiangsu Province Hospital on Integration of Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: • Age 18-80, any gender • Meets Western diagnostic criteria for paroxysmal AF • Meets any TCM syndrome differentiation type of "Rapid Pulse Syndrome" • Additional criteria for PCT subgroup: Undergone catheter ablation (radiofrequency/cryoballoon/pulsed-field) with successful pulmonary vein isolation.

Exclusion criteria

Exclusion criteria: • Persistent/permanent AF • Severe organic heart disease (e.g., significant valvular disease requiring surgery, uncorrected congenital heart disease, hypertrophic obstructive cardiomyopathy) • Severe hepatic/renal dysfunction (ALT/AST >3×ULN; eGFR <30 ml/min/1.73m²) • Malignancy with life expectancy <2 years • Pregnancy/lactation • Participation in other interventional trials • Allergy to study TCM components • Psychiatric disorders affecting follow-up • Severe post-ablation complications within 24h (cardiac tamponade, major vascular injury)

Design outcomes

Primary

MeasureTime frame
AF recurrence rate within 24 weeks;

Secondary

MeasureTime frame
Recurrence frequency per unit time;AF Burden;Time to first AF recurrence (TTFR);Average sinus rhythm conversion time;Non-pharmacological conversion rate;Sinus rhythm maintenance duration (SRMD);Sinus rhythm maintenance rate in efficacy population;Progression to persistent AF rate;TCM syndrome score reduction rate;AFEQT score change from baseline;EQ-5D-5L score change from baseline;EHRA symptom class change;Clinical endpoint event rate;

Countries

China

Contacts

Public ContactWang Xindong

Jiangsu Province Hospital on Integration of Chinese and Western Medicine

wangxd@njucm.edu.cn13655188838

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026