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

U

University of Sao Paulo General Hospital

Status

Unknown

Conditions

Bradycardia

Treatments

Procedure: Transvenous cardiac pacing guided by fluoroscopy
Procedure: Transvenous cardiac pacing guided by ECG/ECHO

Study type

Interventional

Funder types

Other

Identifiers

NCT03037333
PSInCor-EMERG-TV-PAC

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 2 patient groups

fluoroscopy
Other group
Treatment:
Procedure: Transvenous cardiac pacing guided by fluoroscopy
ECG/ECHO
Other group
Treatment:
Procedure: Transvenous cardiac pacing guided by ECG/ECHO

Trial contacts and locations

1

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Central trial contact

Alexandre Soeiro, MD

Data sourced from clinicaltrials.gov

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