Tests pulsed field ablation against drugs in persistent atrial fibrillation with HFpEF
Compares a pulsed field heart procedure with medicines in adults with irregular heartbeat.
Plain-language title generated from the registry record
Registry title: The Safety and Efficacy of Pulsed Field Ablation for Patients With Persistent Atrial Fibrillation Comorbid With HFpEF.
Key facts
- Where
- Nantong, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07077811, who can take part
Where in China
- Affiliated Hospital of Nantong UniversityNantong, 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
- Affiliated Hospital of Nantong University
- Trial code
- NCT07077811
- Record updated
- 22 July 2025
- Original description
The goal of this clinical trial is to evaluate the the mid- and long-term clinical efficacy and safety of pulsed field catheter ablation for patients with persistent atrial fibrillation and HFpEF. The main questions it aims to answer are:Read full original descriptionShow less
The Safety and Efficacy of Pulsed Field Ablation for Patients With Persistent Atrial Fibrillation Comorbid With HFpEF: a Prospective, Multicenter Cohort Study
The goal of this clinical trial is to evaluate the the mid- and long-term clinical efficacy and safety of pulsed field catheter ablation for patients with persistent atrial fibrillation and HFpEF. The main questions it aims to answer are:
* What are the differences between the effects of pulsed field ablation and drug therapy? * Which risk factors affecting the outcome of atrial fibrillation ablation, postoperative recurrence, and improvement of cardiac function? Researchers will compare pulsed field ablation to drug therapy to provide some theoretical basis and clinical evidence for the treatment strategy of patients with atrial fibrillation and HFpEF.
This study selected patients with persistent AF and HFpEF and divided them into a drug group (treated with class I or class III antiarrhythmic drugs) and a surgical group (Medtronic Pulse Select pulsed field ablation).
Inclusion: Age 18-80 years; Patients with persistent atrial fibrillation; According to the 2021 European Society of Cardiology (ESC) guidelines for heart failure, heart failure with preserved ejection fraction (HFpEF) is defined as patients with preserved or slightly reduced left ventricular ejection fraction (LVEF) but with diastolic dysfunction. The diagnostic criteria for HFpEF include: symptoms and signs of heart failure; LVEF≥50%; and objective evidence of cardiac structural and functional abnormalities consistent with left ventricular diastolic dysfunction or increased left ventricular filling pressure. These can be verified by imaging examinations such as echocardiography and biomarkers such as B-type natriuretic peptide or NT-proBNP. The thresholds for B-type natriuretic peptide or NT-proBNP are: BNP≥35 pg/mL or NT-proBNP ≥125 pg/mL for patients with sinus rhythm; BNP≥105 pg/mL or NT-proBNP ≥365 pg/mL for patients with atrial fibrillation; Agree to participate in this study and sign the informed consent form. Have clinical compliance to complete the postoperative follow-up required by the protocol.
Exclusion: Patients who had used class I or class III antiarrhythmic drugs, but the use of the above drugs for less than 7 days to convert atrial fibrillation was allowed; Previous left atrial ablation or surgery (including left atrial appendage occlusion); Previous pulmonary vein stenting; Previous pulmonary vein stenosis; Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI)/percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting within three months before signing the informed consent; Patients with known drug or alcohol addiction; Presence of any heart valve prosthesis; Unstable angina or severe coronary artery stenosis; Primary pulmonary hypertension; Rheumatic heart disease; Any disease that prohibits long-term anticoagulation; Active systemic infection; Patients with malignant tumors; Patients with persistent atrial fibrillation lasting for more than 3 years; Left atrial diameter > 50 mm; Thrombocytosis, thrombocytopenia; Atrial fibrillation caused by reversible causes, such as hyperthyroidism; Women known to be pregnant or breastfeeding; Life expectancy of less than one year; Patients with intracardiac thrombus; Patients who are unwilling or unable to fully comply with the study protocol and complete follow-up; Participating in other clinical trials that may interfere with the results.