NCT05513482

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

Prospective Evaluation of Diaphragm Kinetics With Tissue Doppler Imaging in Patients Undergoing Atrial Fibrillation Ablation With Cryoballoon

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Phrenic Nerve Paralysis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Tissue Doppler Imaging	With tissue Doppler ultrasonography (TDI), the maximum contraction rate of the diaphragm, maximum relaxation rate, and integral against time will be examined.
DIAGNOSTIC_TEST	M Mode Imaging	Diaphragm displacement during inspiration and expiration will be measured with M mode imaging

Timeline

• Start date: 2022-01-23
• Primary completion: 2024-01-30
• Completion: 2024-04-01
• First posted: 2022-08-24
• Last updated: 2023-01-31

Locations

1 site across 1 country: Turkey (Türkiye)