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

NCT07612241 | Not Yet Recruiting

• 1 other identifier: XJLL-KY-20262105
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Gastric Motility After Pulsed Field Versus Radiofrequency 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

Study Arms (2)

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

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

Interventions

Pulsed Field Ablation PROCEDURE

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

Pulsed Field Ablation(PFA) Group

Radiofrequency Ablation PROCEDURE

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

Radiofrequency Ablation(RFA) Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital, Air Force Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Fu Yi

  The First Affiliated Hospital of Air Force Medicial University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fu Yi

CONTACT

+8613572100232; yi12fu56@126.com

Zi Hao

CONTACT

+8618220244424; 18220244424@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)