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

NCT06617442 | Completed

• 1 other identifier: 8088-2/2022/EÜIG
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Thermal injury detected during post-procedural endoscopy

  Composite of esophageal ulcer or erosion and gastric hypomotility.

  Post-procedural endoscopy was performed within 15 days after the procedure.

Study Arms (2)

90W

EXPERIMENTAL

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

Procedure: Pulmonary vein isolation

50W

ACTIVE COMPARATOR

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

Procedure: Pulmonary vein isolation

Interventions

Pulmonary vein isolation PROCEDURE

First pulmonary vein isolation performed for atrial fibrillation.

50W; 90W

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University Heart and Vascular Center

Budapest, Hungary, 1122, Hungary

Location

MeSH Terms

Conditions

Atrial Fibrillation; Esophageal Perforation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, open label

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: February 16, 2022
• Primary Completion: July 4, 2024
• Study Completion: July 4, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)