MedTrace Logo

Non Fluoroscopic APpROach iN atriaL Fibrillation Ablation procEdureS

NCT05319769 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-04-08

No results posted yet for this study

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. 25 patients who performed this procedure according to the classic approach, ie under fluoroscopic guidance;
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.

Clinical efficacy will be assessed through a cardiological checkup and 24-hour electrocardiographic recording (ECG Holter) at 6 months.

Conditions

Interventions

PROCEDURE

Atrial fibrillation ablation

Pulmonary vein isolation

Sponsors & Collaborators

  • University Hospital of Ferrara

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-06-30
Completion
2021-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05319769 on ClinicalTrials.gov