Ultrasonography Evaluation of Diaphragm Kinetics in Patients Undergoing Atrial Fibrillation Ablation With Cryoballoon

Recruiting

• Conditions: Atrial Fibrillation; Phrenic Nerve Paralysis
• Interventions: Diagnostic Test: Tissue Doppler Imaging; Diagnostic Test: M Mode Imaging

• Registration Number: NCT05513482
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief Summary

The purpose of this study to assess the diaphragm kinetics with Tissue Doppler Imaging in patients undergoing atrial fibrillation ablation with cryoballoon

Detailed Description

This study is designed to evaluate the diaphragm kinetics with ultrasonography parameters in patients who underwent pulmonary vein isolation (PVI) for atrial fibrillation (AF) by Cryoballoon. Due to the proximity of the pulmonary veins to the phrenic nerve, phrenic nerve paralysis can be seen rarely during the procedure. In contemporary practice, phrenic nerve damage is detected by visual monitoring of diaphragm movement as a result of pacing with high output by placing the intracardiac stimulation catheter at the level of the superior vena cava. However, subclinical nerve damage may be critical regarding respiratory functions, especially in patients with comorbidities. It has been shown in the literature that the evaluation of diaphragm kinetics with Tissue Doppler Imaging (TDI) can be used in effective ventilation monitoring and weaning. However, this technique has not been used in patients who have previously undergone cryoballoon therapy. It is aimed to investigate the positive or negative effects on diaphragm kinetics, as a very cost-effective and rapidly accessible technique, with the help of this technique.

Study Timeline

• Study Start: 2022-01-23
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-23
• Study First Posted: 2022-08-24
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-28
• Last Update Posted: 2023-01-31
• Primary Completion: 2024-01-30
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients scheduled for AF ablation with a cryoballoon
• ≥18 years old
• Patients with interpretable diaphragm ultrasound before the operation
• Patients giving informed consent

Exclusion Criteria

• Patients who did not give consent
• Patients with phrenic nerve palsy
• Morbid obesity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cryoballoon pulmonary vein isolation for atrial fibrillation ablation	Tissue Doppler Imaging	Diaphragmatic kinetics of participants before and after pulmonary vein isolation will be evaluated with the Tissue Doppler and M Mode Imaging.
Cryoballoon pulmonary vein isolation for atrial fibrillation ablation	M Mode Imaging	Diaphragmatic kinetics of participants before and after pulmonary vein isolation will be evaluated with the Tissue Doppler and M Mode Imaging.

Primary Outcome Measures

Name	Time	Method
Detection of subclinical phrenic nerve injury with changes in diaphragm kinetics, before and after the procedure	Preoperative baseline and postoperative first hour	Unlike the traditional method, diaphragm Tissue Doppler imaging (TDI) will be used to diagnose phrenic nerve injury in patients during cryoballoon ablation. This method aims to detect the damages that may have occurred even though no visible damage has occurred. The peak contraction velocity (PCV) that has been found to be effective on weaning success will be used in TDI. The literature shows that the PCV measured by TDI in healthy humans is 1.32 ⨦ 0.39 cm/sec. Based on this, the patient's baseline and post-procedure PCVs will be compared.

Secondary Outcome Measures

Name	Time	Method
The effect of subclinical diaphragm damage on morbidity	Preoperative baseline and postoperative 24 hours	Side effects that may occur as a consequence of these will be observed in patients with subclinical diaphragm injury.

Trial Locations

Locations (1)

Istanbul University-Cerrahpasa; 🇹🇷 Istanbul, Turkey