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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05513482
• Other study ID #: 2022/449352
• Status: Recruiting
• Start date: January 23, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: January 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Deniz Mutlu, MD
• Phone: +902124143000
• Email: deniz.mutlu92[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 1, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paralysis
• Phrenic Nerve Paralysis

Intervention

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.
• M Mode Imaging
Diaphragm displacement during inspiration and expiration will be measured with M mode imaging

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Cammarota G, Boniolo E, Santangelo E, De Vita N, Verdina F, Crudo S, Sguazzotti I, Perucca R, Messina A, Zanoni M, Azzolina D, Navalesi P, Longhini F, Vetrugno L, Bignami E, Della Corte F, Tarquini R, De Robertis E, Vaschetto R. Diaphragmatic Kinetics Ass — View Citation

Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder I — View Citation

Soilemezi E, Savvidou S, Sotiriou P, Smyrniotis D, Tsagourias M, Matamis D. Tissue Doppler Imaging of the Diaphragm in Healthy Subjects and Critically Ill Patients. Am J Respir Crit Care Med. 2020 Oct 1;202(7):1005-1012. doi: 10.1164/rccm.201912-2341OC. — View Citation

Tokuda M, Yamashita S, Sato H, Oseto H, Ikewaki H, Yokoyama M, Isogai R, Tokutake KI, Yokoyama KI, Kato M, Narui R, Tanigawa SI, Matsuo S, Yoshimura M, Yamane T. Long-term course of phrenic nerve injury after cryoballoon ablation of atrial fibrillation. S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of subclinical phrenic nerve injury with changes in diaphragm kinetics, before and after the procedure	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.	Preoperative baseline and postoperative first hour
Secondary	The effect of subclinical diaphragm damage on morbidity	Side effects that may occur as a consequence of these will be observed in patients with subclinical diaphragm injury.	Preoperative baseline and postoperative 24 hours