Analysis in the EMERGEncy Between TransVenous Cardiac PACIng Guided by Fluoroscopy Versus Echocardiogram (EMERG-TV-PAC)

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

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.

Study Overview

• Status: Unknown
• Conditions: Bradycardia
• Intervention / Treatment: Procedure: Transvenous cardiac pacing guided by fluoroscopy; Procedure: Transvenous cardiac pacing guided by ECG/ECHO

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05.417-000
      • Recruiting
      • Instituto do Coração - HMFMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: fluoroscopy	Procedure: Transvenous cardiac pacing guided by fluoroscopy; Transvenous cardiac estimulation
Other: ECG/ECHO	Procedure: Transvenous cardiac pacing guided by ECG/ECHO; Transvenous cardiac estimulation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to start the correct cardiac stimulation with transvenous pacing	minutes scale	1 week
rates of success	ECG test	1 week

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Alexandre Soeiro, MD, Unidade Clínica de Emergência

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Epub 2015 Mar 5.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: January 18, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: echocardiogram; fluoroscopy; Electrocardiogram: Electrical Alternans
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Emergencies; Bradycardia
• Other Study ID Numbers: PSInCor-EMERG-TV-PAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No