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ENROLLING BY INVITATION
NCT07835126
NA

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

Sponsor: First Affiliated Hospital of Ningbo University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

86

Start Date

2025-10-06

Completion Date

2027-02-25

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

PROCEDURE

vHPSD Ablation with Half-Normal Saline

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

PROCEDURE

vHPSD Ablation with Normal Saline

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

Locations (1)

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China