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Prevention study for Persistent Atrial Fibrillation
Official title Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule
ClinicalTrials.gov ID: NCT07508618
What this study is testing
What is Qi Dong Yi Xin Granules?
Qi Dong Yi Xin Granules is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for persistent atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18-80 years (inclusive);
- Diagnosed with non-valvular persistent atrial fibrillation, having failed at least one antiarrhythmic drug treatment, and scheduled to undergo...
- 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...
You likely can't join if
- Valvular atrial fibrillation or paroxysmal atrial fibrillation
- NYHA functional class IV or LVEF \ 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;
See the full eligibility 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...
- Valvular atrial fibrillation or paroxysmal atrial fibrillation
- NYHA functional class IV or LVEF \ 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, China
- Huzhou, China
- Ningbo, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, China; Huzhou, China; Ningbo, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.