Catheter ablation versus heart rhythm drugs for atrial fibrillation with heart failure
Compares catheter ablation with rhythm drugs in adults with atrial fibrillation and preserved-ejection-fraction heart failure.
Plain-language title generated from the registry record
Registry title: Atrial Fibrillation with Heart Failure with Preserved Ejection Fraction: Treatment Strategies-Catheter Ablation Vs. Anti-Atrial Arrhythmia Drugs
Key facts
- Where
- Shanghai, ChinaSee the site
Where in China
- Shanghai Chest HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Chest Hospital
- Trial code
- NCT06740539
- Record updated
- 18 December 2024
- Original description
A comparison of whether catheter ablation improves the prognosis (all-cause mortality and/or the composite endpoint of MACE) and reduces the recurrence rate of atrial fibrillation (AF) in patients with AF and heart failure with preserved ejection fraction (HFpEF), compared to anti-atrial arrhythmia drugs (AAD). This trial was randomly divided into two groups: the anti-AAD drug group and the catheter ablation group.Read full original descriptionShow less
Atrial Fibrillation with Heart Failure with Preserved Ejection Fraction: Treatment Strategies-Catheter Ablation Vs. Anti-Atrial Arrhythmia Drugs
A comparison of whether catheter ablation improves the prognosis (all-cause mortality and/or the composite endpoint of MACE) and reduces the recurrence rate of atrial fibrillation (AF) in patients with AF and heart failure with preserved ejection fraction (HFpEF), compared to anti-atrial arrhythmia drugs (AAD). This trial was randomly divided into two groups: the anti-AAD drug group and the catheter ablation group.
Inclusion: Age ≥18 years; The patient is willing and able to comply with the protocol and has provided written informed consent; Paroxysmal or persistent atrial fibrillation (AF).（Persistent AF was defined as AF which is sustained beyond 7 days, or lasting less than seven days but necessitating pharmacologic or electric cardioversion. Included within the category of persistent AF is 'long-standing persistent AF', defined as continuous AF of >1-year duration. AF episodes had to be documented in the last 3 months prior to enrollment by ECG, Holter ECG, Loop Recorder, memory of the implanted device (ICD/CRT-D), or any other suitable device.）; Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs; Diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF).（(1) a history of hospitalization for HF with symptoms classified as New York Heart Association (NYHA) class II, III, or IV; (2) LVEF ≥ 50%; (3) at least one of the following cardiac structural abnormalities identified by echocardiography: left ventricular hypertrophy, left atrial enlargement, or diastolic dysfunction; and (4) elevated levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), with a threshold of ≥400 pg/mL for pa-tients with SR at admission and ≥600 pg/mL for patients with AF at admis-sion.); New York Heart Association class II, III, or IV.
Exclusion: Previous left heart ablation procedure for AF; Contraindication to chronic anticoagulation therapy or heparin; Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment; Enrollment in another investigational drug or device study, or participation in another telemonitoring concept; Listed for heart transplant; Cardiac assist device implanted; Requirement for dialysis due to terminal renal failure; Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age; Documented left atrial diameter >6 cm, optimally from the parasternal long-axis view; Planned cardiovascular intervention; Life expectancy ≤ 12 months; Mental or physical inability to participate in the study.