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New treatment option for Atrial Fibrillation, Persistent
Official title Comparison of Catheter Plus Marshall Vein Ablation vs. Catheter Ablation Alone in Persistent AF With Heart Failure
ClinicalTrials.gov ID: NCT06578793
What this study is testing
- What it's testing
- This multicenter, randomized controlled trial aims to compare the clinical efficacy and safety of combining catheter ablation with Marshall vein ethanol ablation versus catheter ablation alone in patients with persistent atrial fibrillation (AF) and concomitant heart failure. Persistent AF is a common arrhythmia that significantly impacts the quality of life and survival rates, especially when coexisting with heart failure.
- Which group you join is decided by chance.
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 between 18 and 80 years
- For symptomatic patients with persistent atrial fibrillation: At least a 6-month history of atrial fibrillation; atrial fibrillation duration...
- Diagnosed with heart failure: Echocardiogram showing left ventricular ejection fraction (LVEF) ≤40%
- Patient willing to receive medication or surgical treatment
- Patient willing to comply with the requirements before the study, during the study, and during follow-up and to sign an informed consent form
You likely can't join if
- Presence of thrombus in the left atrium
- Left atrial diameter greater than 65 millimeters in the parasternal long-axis view, or left atrial volume exceeding 200 milliliters as measured by...
- Presence of significant congenital abnormalities or medical issues, deemed by the researcher as inappropriate for participation in the study
- Reversible causes of atrial fibrillation, such as pericarditis, thyroid disease, acute alcohol intoxication, recent major surgery, or trauma
- Currently suffering from valvular heart disease requiring surgical intervention
- Currently suffering from coronary artery disease requiring surgical or percutaneous intervention
See the full eligibility criteria
- Age between 18 and 80 years
- For symptomatic patients with persistent atrial fibrillation: At least a 6-month history of atrial fibrillation; atrial fibrillation duration exceeding 7 days without spontaneous conversion to sinus rhythm; at least two...
- Diagnosed with heart failure: Echocardiogram showing left ventricular ejection fraction (LVEF) ≤40%
- Patient willing to receive medication or surgical treatment
- Patient willing to comply with the requirements before the study, during the study, and during follow-up and to sign an informed consent form
- Capable of completing a 6-minute walk test
- For women of childbearing potential, a negative pregnancy test result is required
- Presence of thrombus in the left atrium
- Left atrial diameter greater than 65 millimeters in the parasternal long-axis view, or left atrial volume exceeding 200 milliliters as measured by MRI or CT
- Presence of significant congenital abnormalities or medical issues, deemed by the researcher as inappropriate for participation in the study
- Reversible causes of atrial fibrillation, such as pericarditis, thyroid disease, acute alcohol intoxication, recent major surgery, or trauma
- Currently suffering from valvular heart disease requiring surgical intervention
- Currently suffering from coronary artery disease requiring surgical or percutaneous intervention
- History of atrioventricular node ablation
- Liver failure
- Renal failure requiring dialysis
- Contraindicated use of appropriate anticoagulation therapy
- Participation in other experimental drug or device studies
- Severe pulmonary disease
- Previous catheter ablation for atrial fibrillation in the left atrium
- Documented thromboembolic event within the past 90 days
- Pregnant women
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, 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 Changsha, Hunan, 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.