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

Trial details

Who runs it

First Affiliated Hospital of Ningbo University

Trial code

NCT07835126

Record updated

2 October 2026

Original description

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 full original descriptionShow less

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.

Inclusion: 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.

Exclusion: Patients with myocardial infarction or unstable angina within 1 month prior to enrollment; 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; Patients with severe heart failure (NYHA Class IV); 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.); Hemodynamically unstable patients or those in critical condition requiring emergency surgery; Presence or suspicion of infective endocarditis or systemic active infection; Any other condition considered by the investigator as unsuitable for participation; 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; Presence of intracardiac thrombus, tumor, or vegetation; Absence of the inferior vena cava, or presence of thrombus, severe stenotic/occlusive lesions in the interventional access route; Pregnant or lactating women, individuals planning pregnancy within 1 year, or those unwilling to use effective contraception.

ClinicalTrials.gov NCT07835126