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

Bradycardia Clinical Trial

— EMERG-TV-PAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03037333
• Other study ID #: PSInCor-EMERG-TV-PAC
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2017
• Est. completion date: August 2019

Study information

• Verified date: October 2018
• Source: University of Sao Paulo General Hospital
• Contact: Alexandre Soeiro, MD
• Phone: 55-11-2661-5299
• Email: alexandre.soeiro[@]bol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Emergencies

Intervention

Procedure:
• Transvenous cardiac pacing guided by fluoroscopy
Transvenous cardiac estimulation
• Transvenous cardiac pacing guided by ECG/ECHO
Transvenous cardiac estimulation

Locations

Country	Name	City	State
Brazil	Instituto do Coração - HMFMUSP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Bouaziz H, Zetlaoui PJ, Pierre S, Desruennes E, Fritsch N, Jochum D, Lapostolle F, Pirotte T, Villiers S. Guidelines on the use of ultrasound guidance for vascular access. Anaesth Crit Care Pain Med. 2015 Feb;34(1):65-9. doi: 10.1016/j.accpm.2015.01.004. — View Citation

Esmaiel A, Hassan J, Blenkhorn F, Mardigyan V. The Use of Ultrasound to Improve Axillary Vein Access and Minimize Complications during Pacemaker Implantation. Pacing Clin Electrophysiol. 2016 May;39(5):478-82. doi: 10.1111/pace.12833. Epub 2016 Mar 23. — View Citation

Reusz G, Csomos A. The role of ultrasound guidance for vascular access. Curr Opin Anaesthesiol. 2015 Dec;28(6):710-6. doi: 10.1097/ACO.0000000000000245. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		1 week
Primary	infection	Incidence of infection assessed by a clinical diagnosis	1 week
Primary	hematoma > 5 cm	image	1 week
Primary	cardiac perforation	Incidence of cardiac perforation assessed by a clinical diagnosis	1 week
Primary	pneumothorax	Incidence of pneumothorax assessed by a clinical diagnosis	1 week
Primary	ventricular tachycardia	Incidence of ventricular tachycardia assessed by an ECG test	1 week
Primary	loss of capture	Incidence of loss of capture assessed by an ECG test	1 week
Primary	venous thrombosis	Incidence of venous thrombosis assessed by an ultrasound	1 week
Primary	any complication the delays definitive pacemaker > 48 hours	clinical diagnosis	1 week
Secondary	Time to start the correct cardiac stimulation with transvenous pacing	minutes scale	1 week
Secondary	rates of success	ECG test	1 week

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