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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03037333

Acronym

EMERG-TV-PAC

Enrollment

150

Registered

2017-01-31

Start date

2017-08-16

Completion date

2019-08-31

Last updated

2018-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia

Keywords

echocardiogram, Electrocardiogram: Electrical Alternans, fluoroscopy

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.

Interventions

PROCEDURETransvenous cardiac pacing guided by fluoroscopy

Transvenous cardiac estimulation

PROCEDURETransvenous cardiac pacing guided by ECG/ECHO

Transvenous cardiac estimulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Contacts

Primary ContactAlexandre Soeiro, MD

alexandre.soeiro@bol.com.br55-11-2661-5299

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026