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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bradycardia

Intervention / Treatment
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* Procedure: Transvenous cardiac pacing guided by fluoroscopy
* Procedure: Transvenous cardiac pacing guided by ECG/ECHO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: fluoroscopy<br> | Procedure: Transvenous cardiac pacing guided by fluoroscopy<br>* Transvenous cardiac estimulation<br>|
| Other: ECG/ECHO<br> | Procedure: Transvenous cardiac pacing guided by ECG/ECHO<br>* Transvenous cardiac estimulation<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluoroscopy, echocardiogram, Electrocardiogram: Electrical Alternans