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

I

Istanbul University - Cerrahpasa (IUC)

Status

Enrolling

Conditions

Phrenic Nerve Paralysis
Atrial Fibrillation

Treatments

Diagnostic Test: Tissue Doppler Imaging
Diagnostic Test: M Mode Imaging

Study type

Observational

Funder types

Other

Identifiers

NCT05513482
2022/449352

Details and patient eligibility

About

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

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Deniz Mutlu, MD

Data sourced from clinicaltrials.gov

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