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Clinical Trials/NCT05513482
NCT05513482
Recruiting
Not Applicable

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

Istanbul University - Cerrahpasa (IUC)1 site in 1 country80 target enrollmentJanuary 23, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
80
Locations
1
Primary Endpoint
Detection of subclinical phrenic nerve injury with changes in diaphragm kinetics, before and after the procedure
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 23, 2022
End Date
April 1, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Deniz Mutlu

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

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

Outcomes

Primary Outcomes

Detection of subclinical phrenic nerve injury with changes in diaphragm kinetics, before and after the procedure

Time Frame: 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 Outcomes

  • The effect of subclinical diaphragm damage on morbidity(Preoperative baseline and postoperative 24 hours)

Study Sites (1)

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