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)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Fu Yi
- Telefoonnummer: +8613572100232
- E-mail: yi12fu56@126.com
Studie Contact Back-up
- Naam: Zi Hao
- Telefoonnummer: +8618220244424
- E-mail: 18220244424@163.com
Studie Locaties
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Xijing Hospital, Air Force Medical University
-
Contact:
- Fu Yi
- Telefoonnummer: +8613572100232
- E-mail: yi12fu56@126.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
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.
|
Pulmonary vein Description isolation combined with left atrial posterior wall isolation using radiofrequency ablation for persistent atrial fibrillation.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Gastric Motility After Pulsed Field Versus Radiofrequency Ablation
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Fu Yi, The First Affiliated Hospital of Air Force Medicial University
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- XJLL-KY-20262105
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .