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

Primary Purpose

Bradycardia

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Transvenous cardiac pacing guided by fluoroscopy

Transvenous cardiac pacing guided by ECG/ECHO

About this trial

This is an interventional treatment trial for Bradycardia focused on measuring echocardiogram, Electrocardiogram: Electrical Alternans, fluoroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Instituto do Coração - HMFMUSPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

fluoroscopy

ECG/ECHO

Arm Description

Outcomes

Primary Outcome Measures

all cause mortality

infection

Incidence of infection assessed by a clinical diagnosis

hematoma > 5 cm

image

cardiac perforation

Incidence of cardiac perforation assessed by a clinical diagnosis

pneumothorax

Incidence of pneumothorax assessed by a clinical diagnosis

ventricular tachycardia

Incidence of ventricular tachycardia assessed by an ECG test

loss of capture

Incidence of loss of capture assessed by an ECG test

venous thrombosis

Incidence of venous thrombosis assessed by an ultrasound

any complication the delays definitive pacemaker > 48 hours

clinical diagnosis

Secondary Outcome Measures

Time to start the correct cardiac stimulation with transvenous pacing

minutes scale

rates of success

ECG test

Full Information

NCT ID

NCT03037333

First Posted

January 18, 2017

Last Updated

October 23, 2018

Sponsor

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03037333

Brief Title

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

Acronym

EMERG-TV-PAC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 16, 2017 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bradycardia

Keywords

echocardiogram, Electrocardiogram: Electrical Alternans, fluoroscopy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

fluoroscopy

Arm Type

Other

Arm Title

ECG/ECHO

Arm Type

Other

Intervention Type

Procedure

Intervention Name(s)

Transvenous cardiac pacing guided by fluoroscopy

Intervention Description

Transvenous cardiac estimulation

Intervention Type

Procedure

Intervention Name(s)

Transvenous cardiac pacing guided by ECG/ECHO

Intervention Description

Transvenous cardiac estimulation

Primary Outcome Measure Information:

Title

all cause mortality

Time Frame

1 week

Title

infection

Description

Incidence of infection assessed by a clinical diagnosis

Time Frame

1 week

Title

hematoma > 5 cm

Description

image

Time Frame

1 week

Title

cardiac perforation

Description

Incidence of cardiac perforation assessed by a clinical diagnosis

Time Frame

1 week

Title

pneumothorax

Description

Incidence of pneumothorax assessed by a clinical diagnosis

Time Frame

1 week

Title

ventricular tachycardia

Description

Incidence of ventricular tachycardia assessed by an ECG test

Time Frame

1 week

Title

loss of capture

Description

Incidence of loss of capture assessed by an ECG test

Time Frame

1 week

Title

venous thrombosis

Description

Incidence of venous thrombosis assessed by an ultrasound

Time Frame

1 week

Title

any complication the delays definitive pacemaker > 48 hours

Description

clinical diagnosis

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Time to start the correct cardiac stimulation with transvenous pacing

Description

minutes scale

Time Frame

1 week

Title

rates of success

Description

ECG test

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandre Soeiro, MD

Phone

55-11-2661-5299

Ext

4061

alexandre.soeiro@bol.com.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandre Soeiro, MD

Organizational Affiliation

Unidade Clínica de Emergência

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto do Coração - HMFMUSP

City

São Paulo

State/Province

ZIP/Postal Code

05.417-000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexandre Soeiro, MD

Phone

5511-2661-5299

alexandre.soeiro@bol.com.br

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26880272

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.

Results Reference

result

PubMed Identifier

26539789

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.

Results Reference

result

PubMed Identifier

25829319

Citation

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.

Results Reference

result

Links:

URL

https://cardiovascularultrasound.biomedcentral.com/articles/10.1186/s12947-015-0004-9

Description

Related Info

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

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