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

NCT05513482 | Unknown DMC

• 1 other identifier: 2022/449352
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation; Phrenic Nerve Paralysis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The effect of subclinical diaphragm damage on morbidity

  Preoperative baseline and postoperative 24 hours

Study Arms (1)

Cryoballoon pulmonary vein isolation for atrial fibrillation ablation

Diaphragmatic kinetics of participants before and after pulmonary vein isolation will be evaluated with the Tissue Doppler and M Mode Imaging.

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

Interventions

Tissue Doppler Imaging DIAGNOSTIC_TEST

With tissue Doppler ultrasonography (TDI), the maximum contraction rate of the diaphragm, maximum relaxation rate, and integral against time will be examined.

Also known as: GE Vivid T8 Ultrasonography System

Cryoballoon pulmonary vein isolation for atrial fibrillation ablation

M Mode Imaging DIAGNOSTIC_TEST

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

Also known as: GE Vivid T8 Ultrasonography System

Cryoballoon pulmonary vein isolation for atrial fibrillation ablation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study population will consist of patients who are planned for AF ablation with the cryobaloon, whose preoperative ultrasonography can be interpreted and who gave their consent.

You may qualify if:

• Patients scheduled for AF ablation with a cryoballoon
• ≥18 years old
• Patients with interpretable diaphragm ultrasound before the operation
• Patients giving informed consent

You may not qualify if:

• Patients who did not give consent
• Patients with phrenic nerve palsy
• Morbid obesity

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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 IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

  PMID: 32860505 RESULT

• 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.

  PMID: 32614246 RESULT

• 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 Assessment by Tissue Doppler Imaging and Extubation Outcome. Respir Care. 2021 Jun;66(6):983-993. doi: 10.4187/respcare.08702. Epub 2021 Apr 27.

  PMID: 33906957 RESULT

• 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. Sci Rep. 2021 Mar 18;11(1):6226. doi: 10.1038/s41598-021-85618-3.

  PMID: 33737633 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kivanc Yalin, Assoc Prof.

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Central Study Contacts

Deniz Mutlu, MD

CONTACT

+902124143000; deniz.mutlu92@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 24, 2022
• Study Start: January 23, 2022
• Primary Completion: January 30, 2024
• Study Completion: April 1, 2024
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)