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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07612241
Acronym
PFA-GM
Enrollment
20
Registered
2026-05-28
Start date
2026-05-31
Completion date
2026-12-31
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Atrial Fibrillation

Brief summary

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

PROCEDUREPulsed Field Ablation

Pulmonary vein Description isolation combined with left atrial posterior wall isolation using pulsed field ablation for persistent atrial fibrillation.

PROCEDURERadiofrequency Ablation

Pulmonary vein Description isolation combined with left atrial posterior wall isolation using radiofrequency ablation for persistent atrial fibrillation.

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gastric Motility After Pulsed Field Versus Radiofrequency AblationPreoperatively and at 48 hours post-ablationGastric 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.

Countries

China

Contacts

CONTACTFu Yi
yi12fu56@126.com+8613572100232
CONTACTZi Hao
18220244424@163.com+8618220244424
PRINCIPAL_INVESTIGATORFu Yi

The First Affiliated Hospital of Air Force Medicial University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026