Esophageal Safety of High and Very High Power Short Duration Pulmonary Vein Isolation: a Randomized Comparison of the 50W and 90W Power Settings

Not Applicable

Completed

• Conditions: Atrial Fibrillation (AF); Esophageal Perforation; Esophageal Perforation, Traumatic
• Interventions: Procedure: Pulmonary vein isolation

• Registration Number: NCT06617442
• Lead Sponsor: Semmelweis University

Brief Summary

Pulmonary vein isolation (PVI) is the most effective means of maintaining sinus rhythm in atrial fibrillation (AF), while a widely used approach to PVI is point-by-point radiofrequency (RF) catheter ablation. High power short duration (HPSD) and very high power short duration e.g., 90W and 4 sec) are increasingly popular technologies, featuring higher power and shorter application durations compared to previous methods. vHPSD offers similar efficacy to HPSD, while further reducing procedure times. Atrioesophageal fistula (AEF) is a rare but deadly complication of PVI, while endoscopically detected esophageal lesions are surrogate markers for the risk of AEF. Furthermore, thermal complications include vagal lesions leading to gastroparesis. While there is considerable data on the thermal safety of HPSD technology, most studies of vHPSD focus on efficacy and a direct comparison in terms of esophageal safety is lacking. In this randomized, single-center study, we aim to compare the thermal safety of vHPSD to HPSD. Furthermore, we aimed to determine the anatomical and biophysical factors that predict thermal injury. Patients undergoing their first PVI for AF are randomized to either HPSD or vHPSD power setting. The primary endpoint of the study is the composite of esophageal mucosal lesion and gastroparesis, as assessed at the post-procedural endoscopy within 15 days after the PVI.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-16
• Primary Completion: 2024-07-04
• Study Completion: 2024-07-04
• Status Verified: 2024-09
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-25
• Study First Posted: 2024-09-27
• Last Update Posted: 2024-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients with paroxysmal or persistent atrial fibrillation undergoing their first pulmonary vein isolation procedure

Exclusion Criteria

• Additional ablation performed outside PVI
• Contraindications to postoperative upper endoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
90W	Pulmonary vein isolation	Pulmonary vein isolation performed using very-high power short duration applications (90-watt applications lasting 4 seconds).
50W	Pulmonary vein isolation	Pulmonary vein isolation performed using high power short duration applications (50-watt applications guided by ablation index).

Primary Outcome Measures

Name	Time	Method
Thermal injury detected during post-procedural endoscopy	Post-procedural endoscopy was performed within 15 days after the procedure.	Composite of esophageal ulcer or erosion and gastric hypomotility.

Trial Locations

Locations (1)

Semmelweis University Heart and Vascular Center; 🇭🇺 Budapest, Hungary