NCT07077811Enrolling by invitation
The Safety and Efficacy of Pulsed Field Ablation for Patients With Persistent Atrial Fibrillation Comorbid With HFpEF.
The Safety and Efficacy of Pulsed Field Ablation for Patients With Persistent Atrial Fibrillation Comorbid With HFpEF: a Prospective, Multicenter Cohort Study
Source: ClinicalTrials.gov · Last updated 22 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 158 (estimated)
- First submitted
- 15 Jun 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Affiliated Hospital of Nantong University
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT07077811
What you commit to
- Study type: Interventional
- Planned participants: 158
- From 1 Jun 2025 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.