Persistent Atrial FibrillationPFA-GMNCT07612241
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
An observational study of Persistent Atrial Fibrillation, run by Xijing Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Pulsed Field Ablation and Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2026to 31 Dec 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xijing Hospital, Air Force Medical University
Xi'an, Shaanxi, 710032
Fu Yi, +8613572100232, yi12fu56@126.com
About this study
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
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.
Read more
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
- Being tested
- Pulsed Field Ablation, Radiofrequency Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Field AblationProcedure or surgery
Pulmonary vein Description isolation combined with left atrial posterior wall isolation using pulsed field ablation for persistent atrial fibrillation.
Radiofrequency AblationProcedure or surgery
Pulmonary vein Description isolation combined with left atrial posterior wall isolation using radiofrequency ablation for persistent atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperatively and at 48 hours post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start31 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fu Yi, Principal investigator, The First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612241
- Sponsor's protocol ID
- XJLL-KY-20262105
- Acronym
- PFA-GM
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07612241
- Acronym / sponsor ID
- PFA-GM / XJLL-KY-20262105
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 31 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Field Ablation(PFA) Group | – | Procedure: Pulsed Field AblationPatients with persistent atrial fibrillation who undergo pulmonary vein isolation combined with left atrial posterior wall isolation using pulsed field ablation. |
| Radiofrequency Ablation(RFA) Group | – | Procedure: Radiofrequency AblationPatients with persistent atrial fibrillation who undergo pulmonary vein isolation combined with left atrial posterior wall isolation using radiofrequency ablation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Field AblationPulmonary vein Description isolation combined with left atrial posterior wall isolation using pulsed field ablation for persistent atrial fibrillation. | Procedure or surgery | Pulsed Field Ablation(PFA) Group |
| Radiofrequency AblationPulmonary vein Description isolation combined with left atrial posterior wall isolation using radiofrequency ablation for persistent atrial fibrillation. | Procedure or surgery | Radiofrequency Ablation(RFA) Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fu Yi principal investigator
The First Affiliated Hospital of Air Force Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Atrial Fibrillation, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fu Yi (+8613572100232, yi12fu56@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Motility After Pulsed Field Versus Radiofrequency Ablation (time frame: Preoperatively and at 48 hours post-ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.