Non Fluoroscopic APpROach iN atriaL Fibrillation Ablation procEdureS

NCT05319769 | Completed

• 1 other identifier: 234/2022/Oss/AOUFe
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In electrophysiology, interventional procedures are often assisted by fluoroscopic guidance, exposing both patients and healthcare professionals to a considerable dose of radiation. Catheter ablation of atrial fibrillation has frequently involved the use of fluoroscopy: in fact, it incorporates greater complexity due to the need to perform the transseptal puncture. A visible introducer in the 3D electro-anatomical mapping system (which does not involve the use of X-rays), has become an important tool for performing transseptal puncture: in particular, it is positioned at level of the oval fossa of the right atrium (puncture site); subsequently, the needle is introduced inside it; the intervention is guided both by electroanatomical mapping and by the use of intracardiac echocardiography for the identification of important anatomical landmarks. The "zero rays" technique represents a valid alternative to fluoroscopic guidance, widely used and validated over the years. In fact, X-ray exposure in an atrial fibrillation ablation procedure can reach up to 60 mSv: the radiological risk makes it necessary to study safe and effective alternative techniques. In this retrospective, observational and monocentric study, 50 catheter ablation procedures of atrial fibrillation will be examined, divided into two groups:

1. 1.25 patients who performed this procedure according to the classic approach, ie under fluoroscopic guidance;
2. 2.25 patients who performed this procedure using an ablative approach that involved the use of the introducer in combination with the 3D EAM system and intracardiac echocardiography.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; ablation; radiofrequency; intracardiac echocardiography; zero fluoroscopy; arrhythmias

Outcome Measures

Primary Outcomes (3)

• Fluoroscopy time

  Time of X-ray exposure

  Intraprocedure

• DAP

  Dose area product

  Intraprocedure

• Procedural time

  Total procedure time

  Intraprocedure

Secondary Outcomes (3)

• Time for PVI

  Intraprocedure

• Complications

  30 days

• Absence of atrial fibrillation recurrence

  6 months

Study Arms (2)

Zero fluoroscopy

Zero fluoroscopy Patients undergoing AF ablation using the steerable introducer in combination with the 3D EAM system and intracardiac echocardiography. Reconstruction of a bipolar map of the right atrium with a mapping catheter. Then, the interatrial septum is reconstructed and the oval fossa is defined. Transseptal puncture is performed using the steerable introducer (which can be viewed on the EAM) through which, a transseptal needle is introduced. The introducer is positioned at the fossa ovalis. The transseptal needle is advanced to perform the puncture of the septum. After accessing the left atrium, the mapping catheter is introduced iusing the introducer, with which all the structures of the left atrium are mapped. In addition, with intracardiac echocardiography, it is possible to identify important structures such as the pulmonary veins and the esophagus. The pulmonary veins are isolated by means of a catheter.

Procedure: Atrial fibrillation ablation

Traditional approach

Traditional approach Patients who have undergone atrial fibrillation ablation procedure using the traditional approach. The procedure is based on 3D reconstruction using intracardiac ultrasound first and then electroanatomical mapping of the left atrium through a transseptal approach guided by integration of fluoroscopy and intracardiac ultrasound. The transseptal puncture is performed using a transseptal needle which is brought into place using a long introducer with a dilator. The fluoroscopic support is essential as the introducer is not viewable with 3D mapping systems. After accessing the left atrium, through the previously used introducer, a mapping catheter is taken to the left atrium for electro-anatomical reconstruction. Subsequently, the antral pulmonary veins are isolated by means of an ablator catheter with irrigated tip.

Procedure: Atrial fibrillation ablation

Interventions

Atrial fibrillation ablation PROCEDURE

Pulmonary vein isolation

Traditional approach; Zero fluoroscopy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with atrial fibrillation (paroxysmal or persistent) treated with transcatheter ablation

You may qualify if:

• Paroxysmal or persistent atrial fibrillation
• Atrial fibrillation ablation performed during study period
• Clinical follow-up and ECG-Holter recording during follow-up

You may not qualify if:

• Age \< 18 years
• Pregnancy

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Matteo Bertini

Ferrara, 44124, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 8, 2022
• Study Start: June 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: April 8, 2022

Record last verified: 2022-03

Locations

IT (1)