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

NCT ID: NCT03037333

Last Updated: 2018-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-16

Study Completion Date

2019-08-31

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.

Conditions

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Bradycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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fluoroscopy

Group Type OTHER

Transvenous cardiac pacing guided by fluoroscopy

Intervention Type PROCEDURE

Transvenous cardiac estimulation

ECG/ECHO

Group Type OTHER

Transvenous cardiac pacing guided by ECG/ECHO

Intervention Type PROCEDURE

Transvenous cardiac estimulation

Interventions

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Transvenous cardiac pacing guided by fluoroscopy

Transvenous cardiac estimulation

Intervention Type PROCEDURE

Transvenous cardiac pacing guided by ECG/ECHO

Transvenous cardiac estimulation

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandre Soeiro, MD

Role: PRINCIPAL_INVESTIGATOR

Unidade Clínica de Emergência

Locations

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Instituto do Coração - HMFMUSP

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Alexandre Soeiro, MD

Role: CONTACT

55-11-2661-5299 ext. 4061

Facility Contacts

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Alexandre Soeiro, MD

Role: primary

5511-2661-5299

References

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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.

Reference Type RESULT
PMID: 26880272 (View on PubMed)

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.

Reference Type RESULT
PMID: 26539789 (View on PubMed)

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.

Reference Type RESULT
PMID: 25829319 (View on PubMed)

Related Links

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Other Identifiers

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PSInCor-EMERG-TV-PAC

Identifier Type: -

Identifier Source: org_study_id

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