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

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ClinicalTrials.gov Identifier: NCT03037333
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Bradycardia Procedure: Transvenous cardiac pacing guided by fluoroscopy Procedure: Transvenous cardiac pacing guided by ECG/ECHO Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Analysis in the EMERGEncy Between TransVenous Cardiac PACIng Guided by Fluoroscopy Versus Echocardiogram
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
fluoroscopy Procedure: Transvenous cardiac pacing guided by fluoroscopy
Transvenous cardiac estimulation

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




Primary Outcome Measures :
  1. all cause mortality [ Time Frame: 1 week ]
  2. infection [ Time Frame: 1 week ]
    Incidence of infection assessed by a clinical diagnosis

  3. hematoma > 5 cm [ Time Frame: 1 week ]
    image

  4. cardiac perforation [ Time Frame: 1 week ]
    Incidence of cardiac perforation assessed by a clinical diagnosis

  5. pneumothorax [ Time Frame: 1 week ]
    Incidence of pneumothorax assessed by a clinical diagnosis

  6. ventricular tachycardia [ Time Frame: 1 week ]
    Incidence of ventricular tachycardia assessed by an ECG test

  7. loss of capture [ Time Frame: 1 week ]
    Incidence of loss of capture assessed by an ECG test

  8. venous thrombosis [ Time Frame: 1 week ]
    Incidence of venous thrombosis assessed by an ultrasound

  9. any complication the delays definitive pacemaker > 48 hours [ Time Frame: 1 week ]
    clinical diagnosis


Secondary Outcome Measures :
  1. Time to start the correct cardiac stimulation with transvenous pacing [ Time Frame: 1 week ]
    minutes scale

  2. rates of success [ Time Frame: 1 week ]
    ECG test



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037333


Contacts
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Contact: Alexandre Soeiro, MD 55-11-2661-5299 ext 4061 alexandre.soeiro@bol.com.br

Locations
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Brazil
Instituto do Coração - HMFMUSP Recruiting
São Paulo, SP, Brazil, 05.417-000
Contact: Alexandre Soeiro, MD    5511-2661-5299    alexandre.soeiro@bol.com.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Alexandre Soeiro, MD Unidade Clínica de Emergência

Additional Information:
Publications of Results:
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03037333     History of Changes
Other Study ID Numbers: PSInCor-EMERG-TV-PAC
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Sao Paulo General Hospital:
echocardiogram
Electrocardiogram: Electrical Alternans
fluoroscopy

Additional relevant MeSH terms:
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Bradycardia
Emergencies
Disease Attributes
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases