ClinicalTrials.gg
Enrolling by invitationNCT07835126Half SALINE-AFUpdated Oct 2, 2026

Safety and Efficacy of Very High-Power Short-Duration Radiofrequency Ablation With Half-Normal Saline Irrigation for Pulmonary Vein Isolation

An interventional study of vHPSD Ablation with Half-Normal Saline and vHPSD Ablation with Normal Saline in Paroxysmal Atrial Fibrillation, sponsored by First Affiliated Hospital of Ningbo University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by First Affiliated Hospital of Ningbo University · Not applicable, Interventional, and Treatment

Updated Oct 2, 2026Primary completion movedStudy completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Primary Objective: To evaluate the efficacy of the Very High Power Short Duration (vHPSD) ablation mode with half-normal saline irrigation in achieving pulmonary vein isolation (PVI) for atrial fibrillation, by comparing the single-procedure acute pulmonary vein isolation success rate.

Secondary Objective: To assess the safety of the vHPSD ablation mode with half-normal saline irrigation in PVI for atrial fibrillation, by comparing the incidence of steam pops (POPs).

Study Significance This study aims to address the current limitation of insufficient lesion formation in the anterior left atrial wall when using a uniform 90W/4s ablation strategy with normal saline irrigation. By segmenting the left atrium, different irrigation protocols will be applied: 90W/4s ablation with normal saline irrigation will be performed in the posterior area of left atrium, while 90W/4s ablation with half-normal saline irrigation will be performed in the anterior area of left atrium. This approach is anticipated to enhance the procedural immediate success rate (measured by the rate of acute, first-pass PVI), improve overall procedural efficiency, and ensure procedural safety.

02

Conditions studied

  • Paroxysmal Atrial Fibrillation

Browse trials for

Keywords

  • Radiofrequency Ablation
  • Half-Normal Saline Irrigation
  • High-Power Short-Duration
  • Pulmonary Vein Isolation
03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 86 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

First Affiliated Hospital of Ningbo University is the lead sponsor of 27 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 2, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years, both male and female participants are eligible.
  • Diagnosis of paroxysmal atrial fibrillation and scheduled for catheter radiofrequency ablation.
  • The subject or their legal guardian is capable of understanding the study purpose, voluntarily agrees to participate by providing written , and is willing to complete the follow-up as required by the protocol.

Exclusion criteria

Exclusion Criteria:

  • Patients with severe heart failure ( Class IV).
  • Patients with myocardial infarction or unstable angina within 1 month prior to enrollment.
  • Presence of active bleeding, or uncorrected coagulation abnormalities ( count \<50×10⁹/L or >2 times the ).
  • Leukopenia (WBC \<3×10⁹/L) or acute anemia ( \<90 g/L).
  • Hepatic insufficiency ( or AST >3 times the upper limit of normal).
  • Renal insufficiency (serum creatinine ≥3.5 mg/dL), or patients requiring dialysis.
  • Presence of intracardiac thrombus, tumor, or vegetation.
  • Severe structural heart disease deemed by the investigator as potentially interfering with the procedure (e.g., severe mitral, tricuspid, or aortic valve deformity, tetralogy of Fallot, transposition of the great arteries, etc.).
  • Absence of the inferior vena cava, or presence of thrombus, severe stenotic/occlusive lesions in the interventional access route.
  • Hemodynamically unstable patients or those in critical condition requiring emergency surgery.
  • Presence or suspicion of infective endocarditis or systemic active infection.
  • Participation in another clinical trial within 3 months prior to enrollment, or current participation in another drug/device clinical trial without having reached the primary endpoint.
  • Pregnant or lactating women, individuals planning pregnancy within 1 year, or those unwilling to use effective .
  • Any other condition considered by the investigator as unsuitable for participation.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
86 participants (estimated)

Study arms

  • Experimental
    Half-SALINE

    Ablation of the left atrial posterior wall will be performed using 90W/4s applications with normal saline irrigation, while ablation of the left atrial anterior wall will be performed using 90W/4s applications with half-normal saline irrigation.

    Procedure: vHPSD Ablation with Half-Normal Saline

  • Active comparator
    Normal SALINE

    Ablation of both the anterior and posterior walls of the left atrium around the pulmonary veins using 90W/4s model with normal saline irrigation throughout the entire procedure.

    Procedure: vHPSD Ablation with Normal Saline

Interventions

  • ProcedurevHPSD Ablation with Half-Normal Saline

    Left atrial anterior wall ablated with 90W/4s using half-normal saline irrigation; posterior wall with normal saline irrigation.

  • ProcedurevHPSD Ablation with Normal Saline

    Left atrial anterior and posterior walls ablated with 90W/4s using normal saline irrigation throughout the procedure.

06

What researchers measure

Primary outcomes

  1. The efficacy of the Very High-Power Short-Duration (vHPSD) ablation mode with half-normal saline irrigation

    To evaluate the efficacy of the Very High-Power Short-Duration (vHPSD) ablation mode with half-normal saline irrigation in achieving pulmonary vein isolation for atrial fibrillation, by comparing the rate of first-pass isolation.

    Time frame: During ablation procedure

Secondary outcomes

  1. The safety of the Very High-Power Short-Duration (vHPSD) ablation mode with half-normal saline irrigation

    To evaluate the safety of the Very High-Power Short-Duration (vHPSD) ablation mode with half-normal saline irrigation by analyzing the rate of steam pop during all procedure

    Time frame: During ablation procedure

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Dec 2026, 14 months after the start.

Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 14 months is below that.

Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 2, 2026: primary completion Sep 2026 → Dec 2026 and completion Sep 2026 → Feb 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2025
First posted
Sep 22, 2026
StartActual
Oct 6, 2025
Primary completionEst.
Dec 14, 2026was Sep 2026
CompletionEst.
Feb 25, 2027was Sep 2026
Last update
Oct 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Sep 14, 2026→Dec 14, 2026
Oct 2, 2026
Study completion
Sep 14, 2026→Feb 25, 2027
Oct 2, 2026
Eligibility
1 inclusion criterion edited, 1 added
What changed in the criteria
Inclusion criteria
  • Edited- (1) Age ≥ 18 years, both male and female participants are eligible. (2) Diagnosis of paroxysmal atrial fibrillation and scheduled for catheter radiofrequency ablation.
  • AddedDiagnosis of paroxysmal atrial fibrillation and scheduled for catheter radiofrequency ablation.
Oct 2, 2026
Title
Safety and Efficacy of Very High-Power Short-Duration Radiofrequency Ablation With Half-Normal Saline Irrigation for Pulmonary Vein Isolation: A Prospective,Single-center Study
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Primary completion Sep 14, 2026→Dec 14, 2026
    Study completion Sep 14, 2026→Feb 25, 2027
    Eligibility 1 inclusion criterion edited, 1 added
    What changed in the criteria
    Inclusion criteria
    • Edited- (1) Age ≥ 18 years, both male and female participants are eligible. (2) Diagnosis of paroxysmal atrial fibrillation and scheduled for catheter radiofrequency ablation.
    • AddedDiagnosis of paroxysmal atrial fibrillation and scheduled for catheter radiofrequency ablation.
    Title Safety and Efficacy of Very High-Power Short-Duration Radiofrequency Ablation With Half-Normal Saline Irrigation for Pulmonary Vein Isolation: A Prospective,Single-center Study

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07835126
Lead sponsor
First Affiliated Hospital of Ningbo University
Responsible party
Sponsor
First posted
Sep 22, 2026
Start date
Oct 6, 2025
Primary completion
Dec 14, 2026 (estimated)
Completion
Feb 25, 2027 (estimated)
Last update
Oct 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion