Paroxysmal Atrial FibrillationHalf SALINE-AFNCT07835126
Safety and Efficacy of Very High-Power Short-Duration Radiofrequency Ablation With Half-Normal Saline Irrigation for Pulmonary Vein Isolation
A study testing vHPSD Ablation with Half-Normal Saline and vHPSD Ablation with Normal Saline in people with Paroxysmal Atrial Fibrillation, run by First Affiliated Hospital of Ningbo University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- vHPSD Ablation with Half-Normal Saline and vHPSD Ablation with Normal Saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 6 Oct 2025to 25 Feb 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 informed consent, and is willing to complete the follow-up as required by the protocol.
Who cannot join
- Patients with severe heart failure (NYHA Class IV).
- Patients with myocardial infarction or unstable angina within 1 month prior to enrollment.
- Presence of active bleeding, or uncorrected coagulation abnormalities (platelet count <50×10⁹/L or APTT >2 times the upper limit of normal).
- Leukopenia (WBC <3×10⁹/L) or acute anemia (Hb <90 g/L).
- Hepatic insufficiency (ALT or AST >3 times the upper limit of normal).
- Renal insufficiency (serum creatinine ≥3.5 mg/dL), or patients requiring dialysis.
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- 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 contraception.
- Any other condition considered by the investigator as unsuitable for participation.
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
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315020
About this study
Official 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
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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- vHPSD Ablation with Half-Normal Saline, vHPSD Ablation with Normal Saline
- Keywords
- Radiofrequency Ablation, Half-Normal Saline Irrigation, High-Power Short-Duration, Pulmonary Vein Isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vHPSD Ablation with Half-Normal SalineProcedure or surgery
Left atrial anterior wall ablated with 90W/4s using half-normal saline irrigation; posterior wall with normal saline irrigation.
vHPSD Ablation with Normal SalineProcedure or surgery
Left atrial anterior and posterior walls ablated with 90W/4s using normal saline irrigation throughout the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Half-SALINE | Experimental | 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. Receives: Procedure: vHPSD Ablation with Half-Normal Saline |
| Normal SALINE | Active comparator | 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. Receives: Procedure: vHPSD Ablation with Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: During ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start6 Oct 2025
- Primary completion14 Dec 2026 (estimated)
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835126
- Sponsor's protocol ID
- RF20250922
- Acronym
- Half SALINE-AF
- Status last verified
- Sep 2026
- First submitted
- 17 Dec 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07835126
- Acronym / sponsor ID
- Half SALINE-AF / RF20250922
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Radiofrequency Ablation, Half-Normal Saline Irrigation, High-Power Short-Duration, Pulmonary Vein Isolation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 25 Feb 2027 (estimated)
- First posted
- 22 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Half-SALINE | Experimental | Procedure: vHPSD Ablation with Half-Normal SalineAblation 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. |
| Normal SALINE | Active comparator | Procedure: vHPSD Ablation with Normal SalineAblation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 informed consent, and is willing to complete the follow-up as required by the protocol.
Key exclusion criteria (14 listed)
- Patients with severe heart failure (NYHA Class IV).
- Patients with myocardial infarction or unstable angina within 1 month prior to enrollment.
- Presence of active bleeding, or uncorrected coagulation abnormalities (platelet count <50×10⁹/L or APTT >2 times the upper limit of normal).
- Leukopenia (WBC <3×10⁹/L) or acute anemia (Hb <90 g/L).
- Hepatic insufficiency (ALT or AST >3 times the upper limit of normal).
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 |
|---|---|---|
| vHPSD Ablation with Half-Normal SalineLeft atrial anterior wall ablated with 90W/4s using half-normal saline irrigation; posterior wall with normal saline irrigation. | Procedure or surgery | Half-SALINE |
| vHPSD Ablation with Normal SalineLeft atrial anterior and posterior walls ablated with 90W/4s using normal saline irrigation throughout the procedure. | Procedure or surgery | Normal SALINE |
Primary outcome
The efficacy of the Very High-Power Short-Duration (vHPSD) ablation mode with half-normal saline irrigation
Time frame: During ablation procedure
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.
1 secondary outcome
The safety of the Very High-Power Short-Duration (vHPSD) ablation mode with half-normal saline irrigation
Time frame: During ablation procedure
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 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vHPSD Ablation with Half-Normal Saline and vHPSD Ablation with Normal Saline in people with Paroxysmal Atrial Fibrillation, run by First Affiliated Hospital of Ningbo University 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 3 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 2 Oct 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of the Very High-Power Short-Duration (vHPSD) ablation mode with half-normal saline irrigation (time frame: During ablation procedure). 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 Oct 2026.