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Not yet recruiting NCT07612241

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

Observational Persistent Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pulsed Field Ablation, Radiofrequency Ablation.
Who it may be relevant to
Registry conditions: Persistent Atrial Fibrillation. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure Pulsed Field Ablation
    Pulmonary vein Description isolation combined with left atrial posterior wall isolation using pulsed field ablation for persistent atrial fibrillation.
  • Procedure Radiofrequency Ablation
    Pulmonary vein Description isolation combined with left atrial posterior wall isolation using radiofrequency ablation for persistent atrial fibrillation.

Primary outcome measures

  • Gastric Motility After Pulsed Field Versus Radiofrequency Ablation [Time frame: Preoperatively and at 48 hours post-ablation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Xijing Hospital, Air Force Medical University — Xi'an

Identifiers

NCT: NCT07612241 · XJLL-KY-20262105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗