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Persistent Atrial FibrillationPhase 4QDYX-AFNCT07508618

Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule

A Phase 4 study testing Qi Dong Yi Xin Granules in people with Persistent Atrial Fibrillation, run by Sir Run Run Shaw Hospital at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to investigate the efficacy and safety of Qidong Yixin Granules in preventing recurrence in patients after radiofrequency catheter ablation for atrial fibrillation. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Persistent Atrial Fibrillation
What is being tested?
Qi Dong Yi Xin Granules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
846 participants
Where
5 sitesChina
Study dates
9 Feb 2026to 30 Aug 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-80 years (inclusive);
  • Diagnosed with non-valvular persistent atrial fibrillation, having failed at least one antiarrhythmic drug treatment, and scheduled to undergo initial ablation;
  • Voluntarily participate in this study and sign an informed consent form. If the subject is unable to read or sign the informed consent form due to reasons such as lack of capacity, the informed consent process must be completed and signed by their legal guardian. If the subject is unable to read the informed consent form (e.g., illiterate subjects), the informed consent process must be witnessed and signed by a witness.

Who cannot join

  • Valvular atrial fibrillation or paroxysmal atrial fibrillation
  • NYHA functional class IV or LVEF <40%, LA diameter >55mm;
  • Moderate to severe left ventricular hypertrophy (wall thickness >1.5cm);
  • Patients with acute coronary syndrome or requiring stent implantation
  • Patients with a history of cardiac surgery within the past 6 months or previous catheter ablation
  • Duration of atrial fibrillation ≥5 years;
Show all 16Show fewer
  • Hyperthyroidism;
  • Patients with atrial fibrillation and cardiomyopathy;
  • Patients with bradyarrhythmia requiring pacemaker implantation
  • Known bleeding diathesis, presence of left atrial/left atrial appendage thrombus, or severe hemostasis and coagulation dysfunction
  • Severe hepatic or renal insufficiency ALT ≥3 × ULN or eGFR <45 ml/min/1.73 m²;
  • Patients allergic to the components of the study drug;
  • Patients who are currently participating or have participated in other interventional clinical studies within the past 3 months.
  • Pregnant or lactating women, or those with an expected lifespan of <12 months;
  • Other vulnerable groups, excluding the elderly/illiterate individuals, including those with mental illnesses, cognitive impairments, critically ill patients, etc
  • Any other reasons deemed by the investigator as unsuitable for the patient's participation in this study

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lu Yu contact

86 13967126090

jyulu@zju.edu.cn

5 sites in 1 country

China5 sites, 5 recruiting

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou

    Lu Yu, 8613967126090, jyulu@zju.edu.cn

    Lu Yu

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

    DongChen Zhou, (0571)87236114

    Dongchen Zhou

    Not yet recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou

    ZheJun Cai, 0571-87783777

    Dongchen Zhou

    Not yet recruiting

  • Deqing People'S Hospital

    Huzhou

    FangFang Huang, 0572-8818120

    FangFang Huang

    Not yet recruiting

  • Ningbo No.2 Hospital

    Ningbo

    Xianfeng Du, 0574-83870999

    XianFeng Du

    Not yet recruiting

Other trials in China

About this study

Official title: Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule Based on Multicenter Clinical Trials and Omics Mechanisms

The goal of this clinical trial is to investigate the efficacy and safety of Qidong Yixin Granules in preventing recurrence in patients after radiofrequency catheter ablation for atrial fibrillation. The main question it aims to answer is:

Can Qidong Yixin Granules reduce the recurrence rate of atrial fibrillation within 1 year in patients undergoing radiofrequency catheter ablation for atrial fibrillation?

Read more

Participants will be randomly assigned, with a 50% chance of being allocated to either the study group or the control group. Regardless of which group a participant is assigned to, researchers will administer Qidong Yixin Granules or placebo within 48 hours after catheter ablation for atrial fibrillation. Group assignment is determined by computer-generated randomization, and no individual has the authority to interfere with the allocation result.

If a participant is assigned to the study group, they will receive oral Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course.

If a participant is assigned to the control group, they will receive oral placebo matching Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course.

Regardless of the group assignment, all participants will attend outpatient follow-up at 1, 3, 6, 9, and 12 months postoperatively. Electrocardiography (ECG) and ambulatory electrocardiography (Holter monitoring) will be performed at 1, 3, 6, and 12 months after surgery. Transthoracic echocardiography will be conducted at 3 and 12 months postoperatively. Anticoagulation will be administered for at least 3 months after surgery, and subsequent anticoagulation strategies will be determined based on the CHA₂DS₂-VASc score.

Being tested
Qi Dong Yi Xin Granules, Placebo
Keywords
Persistent Atrial Fibrillation, QiDongYiXin
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Qi Dong Yi Xin GranulesDrug

    If a participant is assigned to the study group, they will receive oral Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course.

  • PlaceboDrug

    If a participant is assigned to the control group, they will receive oral placebo matching Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course.

Study groups in NCT07508618
Study groupRoleWhat they receive
Intervention GroupExperimentalIf a participant is assigned to the study group, they will receive oral Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course.
Receives: Drug: Qi Dong Yi Xin Granules
Control GroupPlacebo comparatorIf a participant is assigned to the control group, they will receive oral placebo matching Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The recurrence rate of atrial fibrillation

    Measured: From enrollment to the end of treatment at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2026
  2. Study start9 Feb 2026
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
846 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07508618
Sponsor's protocol ID
SRRSH2025-2022
Acronym
QDYX-AF
Status last verified
Mar 2026
First submitted
27 Mar 2026
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • [1] Li H, Song X, Liang Y, et al. Global, regional, and national burden of atrial fibrillation/flutter, 1990-2019: results from the Global Burden of Disease Study 2019. BMC Public Health. 2022;22(1):2015. [2] Gaudino M, Di Franco A, Rong LQ, Piccini J, Mack M. Postoperative atrial fibrillation: from mechanisms to treatment. Eur Heart J. 2023;44(12):1020-1039. [3] Cosedis Nielsen J, et al. POWDER-AF trial: Effect of continued antiarrhythmic therapy after ablation. N Engl J Med. 2016. [4] Huang H, Liu Y, Shuai W, et al. Atrial tachyarrhythmia prevention by Shensong Yangxin after catheter ablation for persistent atrial fibrillation: the SS-AFRF trial. Eur Heart J. 2024;45(40):4305-4314. [5] 郁一波,陶春兰,方任远,等.稳心颗粒结合氯沙坦钾对房颤射频消融术后心室重构的预防效果及对复发率的影响[J].中华中医药学刊,2023,41(06):191-194. [6] 谭巨浪,胡晓军.中医药治疗心房颤动的临床研究进展[J].中西医结合心血管病电子杂志,2020,8(13):163-164. [7] 高原,吴莹,李彬,等.芪冬颐心颗粒通过抑制Nav1.5和Kv4.3电流改善心肌缺血再灌注心律失常的电生理机制[J].中华中医药杂志,2025,40(04):1883-1891.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Qi Dong Yi Xin Granules in people with Persistent Atrial Fibrillation, run by Sir Run Run Shaw Hospital at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lu Yu (86 13967126090, jyulu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The recurrence rate of atrial fibrillation (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07508618, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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