Pulsed Field Ablation Versus Radiofrequency Ablation: Effects of Pulmonary Vein Isolation Combined With Left Atrial Posterior Wall Isolation on Postoperative Gastric Motility in Patients With Persistent Atrial Fibrillation (PFA-GM)

May 28, 2026 updated by: Xijing Hospital

A Comparative Study on the Effects of Pulmonary Vein Isolation Combined With Left Atrial Posterior Wall Isolation Via Pulsed Field Ablation Versus Radiofrequency Ablation on Postoperative Gastric Motility in Patients With Persistent Atrial Fibrillation

This is a single-center, prospective, matched cohort study comparing the effect of Pulsed Field Ablation (PFA) versus Radiofrequency Ablation (RF) on postoperative gastric motility in patients with persistent atrial fibrillation (AF). A total of 20 patients will be enrolled in a 1:1 matched design (10 PFA, 10 RF), matched by age, gender, left atrial diameter, AF duration, and diabetes history. All patients will undergo pulmonary vein isolation (PVI) plus left atrial posterior wall isolation (LAPWI).

The primary outcome is gastric emptying assessed by radionuclide imaging preoperatively and at 48 hours post-ablation. Secondary outcomes include gastrointestinal symptom scores: PAGI-SYM, GSRS, and GerdQ measured before ablation and at 7 days post-procedure.

Patients with prior AF ablation, upper gastrointestinal surgery, gastroparesis, or recent use of gastrointestinal medications are excluded. The study period is from January 30, 2026 to July 30, 2026.

This study aims to evaluate whether PFA is associated with better gastric motility preservation compared with conventional RF ablation in persistent AF patients undergoing extended PVI plus posterior wall isolation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital, Air Force Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with persistent atrial fibrillation aged 18-80 years, scheduled for first-time catheter ablation (pulsed field or radiofrequency) with pulmonary vein isolation plus left atrial posterior wall isolation at a single center. The study aims to compare postoperative gastric motility between the two ablation modalities.

Description

Inclusion Criteria:

  • Age 18-80 years
  • Diagnosed with persistent atrial fibrillation (AF) according to current guidelines
  • Undergoing first-time catheter ablation (PFA or RF) with planned pulmonary vein isolation plus left atrial posterior wall isolation
  • Able to understand and sign informed consent
  • Able to complete radionuclide gastric emptying scintigraphy and symptom questionnaires

Exclusion Criteria:

  • Previous AF ablation or cardiac surgery
  • History of gastroparesis or severe gastrointestinal disease
  • Prior upper gastrointestinal surgery
  • Use of prokinetic or antisecretory medications within 4 weeks before enrollment
  • Severe renal/hepatic dysfunction or active malignancy
  • Pregnant or breastfeeding women
  • Inability to comply with study procedures or follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pulsed Field Ablation(PFA) Group
Patients with persistent atrial fibrillation who undergo pulmonary vein isolation combined with left atrial posterior wall isolation using pulsed field ablation.
Procedure: Pulsed Field Ablation
Pulmonary vein Description isolation combined with left atrial posterior wall isolation using pulsed field ablation for persistent atrial fibrillation.
Radiofrequency Ablation(RFA) Group
Patients with persistent atrial fibrillation who undergo pulmonary vein isolation combined with left atrial posterior wall isolation using radiofrequency ablation.
Procedure: Radiofrequency Ablation
Pulmonary vein Description isolation combined with left atrial posterior wall isolation using radiofrequency ablation for persistent atrial fibrillation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric Motility After Pulsed Field Versus Radiofrequency Ablation
Time Frame: Preoperatively and at 48 hours post-ablation
Gastric emptying function will be assessed by radionuclide gastric emptying scintigraphy. The primary outcome is the difference in the percentage of gastric retention at 2 hours postprandial between the pulsed field ablation (PFA) group and the radiofrequency ablation (RF) group, measured preoperatively and at 48 hours post-ablation.
Preoperatively and at 48 hours post-ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: Fu Yi, The First Affiliated Hospital of Air Force Medicial University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 31, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJLL-KY-20262105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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