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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06617442
Acronym
HPSD-Esophagus
Enrollment
150
Registered
2024-09-27
Start date
2022-02-16
Completion date
2024-07-04
Last updated
2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF), Esophageal Perforation, Esophageal Perforation, Traumatic

Keywords

Pulmonary Vein Isolation, PVI, HPSD, High Power Short Duration, Esophageal injury

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.

Interventions

PROCEDUREPulmonary vein isolation

First pulmonary vein isolation performed for atrial fibrillation.

Sponsors

Semmelweis University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Randomized, open label

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Thermal injury detected during post-procedural endoscopyPost-procedural endoscopy was performed within 15 days after the procedure.Composite of esophageal ulcer or erosion and gastric hypomotility.

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026