Printed from Voxsanity (voxsanity.com.au) — NCT06883864 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Atrial Fibrillation
Atrial Fibrillation Trial, Recruiting
NCT06883864
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 18 to 80 years old
- People who have been diagnosed with persistent atrial fibrillation (an ongoing irregular heart rhythm), confirmed by a heart tracing (ECG)
- People who have moderate-to-severe or worse leaking of the mitral heart valve (specifically a type linked to atrial fibrillation, not structural valve damage), confirmed by a heart ultrasound taken within 14 days before joining the trial
- People whose heart is pumping at a normal or near-normal level (left ventricular ejection fraction of 50% or higher), confirmed by heart ultrasound within 14 days before joining
- People whose heart chamber and upper heart chamber measurements fall within specific size limits on heart ultrasound, taken within 14 days before joining (confirm exact measurements with trial site)
- People who agree to undergo a catheter ablation procedure (a procedure to treat abnormal heart rhythms) and are willing and able to attend all required follow-up appointments
Who may not be able to join:
- People who have paroxysmal atrial fibrillation (episodes that start and stop on their own), atrial fibrillation caused by a treatable or reversible condition, or who have previously had a catheter ablation procedure
- People whose mitral valve leaking is caused by a structural problem with the valve itself, such as calcium build-up, valve prolapse, infection, rheumatic disease, or damage from a heart attack
- People who have previously had surgery or a catheter-based procedure on their mitral valve
- People whose mitral valve opening is smaller than 4 cm²
- People who have aortic valve disease that requires surgery or a catheter-based procedure to treat
- People who have significant coronary artery disease (blocked heart arteries) that has not yet been treated
- People who have a history of a heart attack
- People who have been diagnosed with a specific heart muscle disease, such as dilated, hypertrophic, restrictive, arrhythmogenic, or infiltrative cardiomyopathies (for example, amyloidosis or hemochromatosis)
- People whose heart ultrasound shows a mass or blood clot inside the heart
- People who already have an implanted cardiac device, such as a pacemaker, defibrillator, cardiac resynchronization device, or a left atrial appendage closure device
- People whose heart is not stable enough without the support of mechanical assist devices
- People who have had a catheter-based heart procedure (such as a coronary stent or a transcatheter valve procedure) within the 30 days before joining
- People who have had heart surgery within the 6 months before joining
- People currently being treated for an active infection with antibiotics
- People who have a known allergy or medical reason they cannot take the medications required for the procedure, if that cannot be managed medically
- People who have a medical reason they cannot take blood-thinning (anticoagulation) medication
- People with severe chronic lung disease (COPD) who need continuous oxygen at home or long-term oral steroid tablets
- People who have had a stroke within the 30 days before joining, or who have significant disability from a previous stroke (confirm disability level with trial site)
- People who have symptomatic severe narrowing of the carotid arteries (the main arteries in the neck), greater than 70% blockage confirmed by ultrasound
- People who have another surgical or procedural treatment planned within the next 3 months
- People with liver failure
- People with kidney failure or who are on dialysis
- People who are pregnant or planning to become pregnant within the next 3 months
- People whose life expectancy is less than 12 months, for example due to advanced cancer
- People who are currently taking part in another interventional clinical trial
- People whom the research team considers unsuitable for participation for other reasons
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
Contact this trial
Principal Investigator: Changsheng Ma, MD, Beijing Anzhen Hospital
Phone: +86 13810720787
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Not Applicable
Sponsor
Beijing Anzhen Hospital
Registry
ClinicalTrials.gov
Start date
8 April 2025
Est. completion
1 August 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
The primary endpoint is the proportion of patients with residual MR of moderate [2+] or less assessed by transthoracic echocardiography at 3 months.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.