Pulsed Field Ablation for Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion

NCT07313228 | Not Yet Recruiting DMC

• 2 other identifiers: NBUFH-2025Y-289AMR-33-25-078136
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-center, prospective, single-arm clinical trial designed to evaluate the safety and efficacy of pulsed field ablation (PFA) after left atrial appendage occlusion (LAAO) in patients with non-valvular atrial fibrillation (AF). The trial will include patients who have undergone successful LAAO and have symptomatic AF that is refractory to or intolerant of class I or III antiarrhythmic drugs. The primary objective is to assess the effectiveness of PFA in preventing AF recurrence and its safety, including the occurrence of serious adverse events. Patients will be followed up for 12 months post-procedure to evaluate outcomes such as recurrence of AF, complications, and device-related issues.

Conditions

Atrial Fibrillation; Left Atrial Appendage Occlusion; Pulsed Field Ablation

Keywords

Atrial Fibrillation; left atrial appendage occlusion; pulsed field ablation

Outcome Measures

Primary Outcomes (1)

• No recurrence of atrial arrhythmias within 12 months

  Defined as the absence of such arrhythmias in the efficacy evaluation period (from blanking period to the end of 12-month follow-up) based on ECG data (including both surface ECG and 24-hour Holter monitoring).

  12month

Secondary Outcomes (1)

• Ablation success

  Instantly

Study Arms (1)

PFA after LAAO group

The patients in this group have previously undergone Left Atrial Appendage Occlusion (LAAO) surgery and are scheduled to undergo Pulsed Field Ablation (PFA). The study will only collect comprehensive data throughout their treatment process without introducing any additional interventions.

Procedure: Pulsed Field Ablation

Interventions

Pulsed Field Ablation PROCEDURE

Pulsed Field Ablation is a surgical technique for atrial fibrillation ablation that uses pulsed electric fields.

PFA after LAAO group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The selected population consists of adult patients with a documented history of atrial fibrillation who have undergone left atrial appendage occlusion and are planned to undergo pulsed field ablation due to ineffective drug treatment. Additionally, they must not have any surgical contraindications.

You may qualify if:

• Aged 18-75 years;
• Documented symptomatic atrial fibrillation;
• Ineffective or intolerant to at least one class I or III antiarrhythmic drug;
• Able to fully understand the treatment protocol, voluntarily sign the informed consent form, and willing to undergo the required examinations, procedures, and follow-up.

You may not qualify if:

• Patients who have previously undergone left atrial surgery;
• Left atrial thrombus;
• Patients with pulmonary agenesis;
• Female patients of reproductive age who cannot use effective contraception within 12 months after enrollment;
• Left atrial anteroposterior diameter ≥ 55 mm;
• Left ventricular ejection fraction (LVEF) ≤ 40%;
• Patients who have previously undergone interatrial septal repair or removal of atrial myxoma;
• Patients with active implanted devices (e.g., pacemaker, ICD);
• Patients with NYHA heart failure class III-IV;
• Patients with a clear history of cerebrovascular disease (including cerebral hemorrhage, stroke, or TIA) within the past 6 months;
• Patients who have experienced cardiovascular events (e.g., acute myocardial infarction, coronary intervention or bypass surgery, valve replacement or repair, atrial or ventricular surgery) within the past 3 months;
• Patients with acute or severe systemic infections;
• Patients with severe liver or kidney disease, malignancy, or end-stage disease that may affect the treatment, assessment, or compliance of the trial (as judged by the investigator);
• Patients with significant bleeding tendency, hypercoagulable state, or severe hematologic disorders;
• Patients who have participated or are currently participating in another clinical trial within the past 12 months prior to enrollment;

Sponsors & Collaborators

• First Affiliated Hospital of Ningbo University: lead

Related Publications (5)

• Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996 Feb;61(2):755-9. doi: 10.1016/0003-4975(95)00887-X.

  PMID: 8572814 BACKGROUND

• Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4.

  PMID: 29103847 BACKGROUND

• Osmancik P, Herman D, Neuzil P, Hala P, Taborsky M, Kala P, Poloczek M, Stasek J, Haman L, Branny M, Chovancik J, Cervinka P, Holy J, Kovarnik T, Zemanek D, Havranek S, Vancura V, Opatrny J, Peichl P, Tousek P, Lekesova V, Jarkovsky J, Novackova M, Benesova K, Widimsky P, Reddy VY; PRAGUE-17 Trial Investigators. Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation. J Am Coll Cardiol. 2020 Jun 30;75(25):3122-3135. doi: 10.1016/j.jacc.2020.04.067.

  PMID: 32586585 BACKGROUND

• Tam MTK, Kojodjojo P, Lam YY, Chow J, Wong C, Kam KK, Wong GLN, Chan CP, Chan JYS, So KC. Combined pulsed field ablation and left atrial appendage occlusion: A multicenter comparative study. Heart Rhythm. 2025 Oct;22(10):2579-2584. doi: 10.1016/j.hrthm.2025.03.1968. Epub 2025 Mar 21.

  PMID: 40122196 BACKGROUND

• Beney J, Galea R, Siontis G, Grani C, Kueffer T, Brugger N, Reichlin T, Raber L, Roten L. Feasibility study on atrial fibrillation ablation with pulsed field ablation and concomitant occlusion of the left atrial appendage. Europace. 2024 Jul 2;26(7):euae176. doi: 10.1093/europace/euae176.

  PMID: 38917059 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jiedong Zhou, PhD

CONTACT

17816533346; 1552882461@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12