NCT07508618 Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule
| NCT ID | NCT07508618 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Sir Run Run Shaw Hospital |
| Condition | Persistent Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 846 participants |
| Start Date | 2026-02-09 |
| Primary Completion | 2027-08-30 |
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.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 846 participants in total. It began in 2026-02-09 with a primary completion date of 2027-08-30.
⚠ 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
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? 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07508618 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Persistent Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07508618 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07508618 currently recruiting?
Yes, NCT07508618 is actively recruiting participants. Contact the research team at jyulu@zju.edu.cn for enrollment information.
Where is the NCT07508618 trial being conducted?
This trial is being conducted at Hangzhou, China, Hangzhou, China, Hangzhou, China, Huzhou, China and 1 additional location.
Who is sponsoring the NCT07508618 clinical trial?
NCT07508618 is sponsored by Sir Run Run Shaw Hospital. The trial plans to enroll 846 participants.
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