The Safety and Efficacy of Pulsed Field Ablation for Patients With Persistent Atrial Fibrillation Comorbid With HFpEF.

NCT07077811 | Enrolling By Invitation

• 1 other identifier: 2025-K119-01
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cardiovascular Diseases; Heart Failure; Atrial Fibrillation (AF); HFpEF - Heart Failure With Preserved Ejection Fraction

Keywords

Persistent Atrial Fibrillation; Heart Failure with Preserved Ejection Fraction; Pulsed field ablation

Outcome Measures

Primary Outcomes (1)

• Change in quality of life at 12 months as measured by the Atrial Fibrillation Quality of Life Survey (AFEQT).

  Improvement in quality of life from baseline to 12 months after pulsed field ablation procedure or AAD as measured by the Atrial Fibrillation Quality of Life Survey (AFEQT), with values ranging from 20 - 140 (higher scores mean worse outcomes).

  12 months

Secondary Outcomes (5)

• The rate of atrial fibrillation-free recurrence

  12 months after surgery

• Complications and adverse events

  perioperative period

• Readmission Rate

  3 months after surgery

• The incidence of AT/AF/AFL events

  3 months after surgery

• Improvement of cardiac function

  6 and 12 months after surgery

Study Arms (2)

Surgical group

EXPERIMENTAL

Medtronic Pulse Select pulsed field ablation Group

Procedure: pulsed field ablation

Drug group

ACTIVE COMPARATOR

Group treated with class I or class III antiarrhythmic drugs

Drug: antiarrhythmic drug

Interventions

pulsed field ablation PROCEDURE

Medtronic Pulse Select pulsed field ablation

Surgical group

antiarrhythmic drug DRUG

treated with class I or class III antiarrhythmic drugs

Drug group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with persistent atrial fibrillation lasting for more than 3 years;
• 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);
• Left atrial diameter \> 50 mm;
• Previous pulmonary vein stenting;
• Previous pulmonary vein stenosis;
• Presence of any heart valve prosthesis;
• 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;
• Unstable angina or severe coronary artery stenosis;
• Primary pulmonary hypertension;
• Rheumatic heart disease;
• Thrombocytosis, thrombocytopenia;
• Any disease that prohibits long-term anticoagulation;
• Active systemic infection;
• Atrial fibrillation caused by reversible causes, such as hyperthyroidism;

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure; Atrial Fibrillation

Interventions

Anti-Arrhythmia Agents

Condition Hierarchy (Ancestors)

Heart Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: July 22, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)