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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05513482
Enrollment
80
Registered
2022-08-24
Start date
2022-01-23
Completion date
2024-04-01
Last updated
2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Phrenic Nerve Paralysis

Keywords

Pulmonary vein isolation, Atrial fibrillation ablation, Arrhythmia, Phrenic nerve, Tissue doppler imaging, Diaphragm kinetics

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.

Interventions

DIAGNOSTIC_TESTTissue 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_TESTM Mode Imaging

Diaphragm displacement during inspiration and expiration will be measured with M mode imaging

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Detection of subclinical phrenic nerve injury with changes in diaphragm kinetics, before and after the procedurePreoperative baseline and postoperative first hourUnlike 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

MeasureTime frameDescription
The effect of subclinical diaphragm damage on morbidityPreoperative baseline and postoperative 24 hoursSide effects that may occur as a consequence of these will be observed in patients with subclinical diaphragm injury.

Countries

Turkey (Türkiye)

Contacts

Primary ContactDeniz Mutlu, MD
deniz.mutlu92@gmail.com+902124143000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026