Analysis in the EMERGEncy Between TransVenous Cardiac PACIng Guided by Fluoroscopy Versus Echocardiogram

Not Applicable

• Conditions: Bradycardia
• Interventions: Procedure: Transvenous cardiac pacing guided by ECG/ECHO; Procedure: Transvenous cardiac pacing guided by fluoroscopy

• Registration Number: NCT03037333
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

A lot of questions about use of temporary transvenous pacing still remain obscure and there is no effective comparison between use of fluoroscopy versus electrocardiogram/echocardiogram in patients with bradicardias. The aim of the study is to evaluate how long does it take to start the correct cardiac stimulation with transvenous pacing in patients with bradicardias comparing use of fluoroscopy versus electrocardiogram/echocardiogram and compare rates of complications between two methods.

Detailed Description

Approximately 150 subjects will be recruited over a planned recruitment period of 18 months. Patients will be submitted to ecchocardiogram using Philips Envisor, and electrocardiogram with Philips Healthcare PageWriter TC30.

Study Timeline

• Study First Submitted: 2017-01-18
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Study Start: 2017-08-16
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-24
• Primary Completion: 2018-12
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• adult males and females aged > 18 years
• symptomatic bradicardia
• informed consent signed.

Exclusion Criteria

• pregnancy
• hemodynamic instability (pulmonary congestion / systolic arterial pressure lower than 90 mmHg)
• body mass index greater than 40 kg/ m2
• use of oral anticoagulation
• acute coronary syndromes
• left ventricle ejection fraction < 45%
• presence of any kind of cardiac stimulation device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECG/ECHO	Transvenous cardiac pacing guided by ECG/ECHO	-
fluoroscopy	Transvenous cardiac pacing guided by fluoroscopy	-

Primary Outcome Measures

Name	Time	Method
cardiac perforation	1 week	Incidence of cardiac perforation assessed by a clinical diagnosis
ventricular tachycardia	1 week	Incidence of ventricular tachycardia assessed by an ECG test
any complication the delays definitive pacemaker > 48 hours	1 week	clinical diagnosis
hematoma > 5 cm	1 week	image
venous thrombosis	1 week	Incidence of venous thrombosis assessed by an ultrasound
infection	1 week	Incidence of infection assessed by a clinical diagnosis
pneumothorax	1 week	Incidence of pneumothorax assessed by a clinical diagnosis
all cause mortality	1 week
loss of capture	1 week	Incidence of loss of capture assessed by an ECG test

Secondary Outcome Measures

Name	Time	Method
Time to start the correct cardiac stimulation with transvenous pacing	1 week	minutes scale
rates of success	1 week	ECG test

Trial Locations

Locations (1)

Instituto do Coração - HMFMUSP; 🇧🇷 São Paulo, SP, Brazil