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

NCT ID: NCT06617442

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-16
• Study Completion Date: 2024-07-04

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

90W

Pulmonary vein isolation performed using very-high power short duration applications (90-watt applications lasting 4 seconds).

Group Type: EXPERIMENTAL

Pulmonary vein isolation

Intervention Type: PROCEDURE

First pulmonary vein isolation performed for atrial fibrillation.

50W

Pulmonary vein isolation performed using high power short duration applications (50-watt applications guided by ablation index).

Group Type: ACTIVE_COMPARATOR

Pulmonary vein isolation

Intervention Type: PROCEDURE

First pulmonary vein isolation performed for atrial fibrillation.

Interventions

Pulmonary vein isolation

First pulmonary vein isolation performed for atrial fibrillation.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Semmelweis University

OTHER

Sponsor Role: lead

Responsible Party

Nandor Szegedi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Semmelweis University Heart and Vascular Center

Budapest, Hungary, Hungary

Countries

Hungary

Other Identifiers

8088-2/2022/EÜIG

Identifier Type: -

Identifier Source: org_study_id