NCT03037333

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

August 16, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

January 18, 2017

Last Update Submit

October 23, 2018

Conditions

Bradycardia

Keywords

echocardiogramElectrocardiogram: Electrical Alternansfluoroscopy

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (2)

  • Time to start the correct cardiac stimulation with transvenous pacing

    1 week

  • rates of success

    1 week

Study Arms (2)

fluoroscopy

OTHER
Procedure: Transvenous cardiac pacing guided by fluoroscopy

ECG/ECHO

OTHER
Procedure: Transvenous cardiac pacing guided by ECG/ECHO

Interventions

Transvenous cardiac pacing guided by fluoroscopyPROCEDURE

Transvenous cardiac estimulation

fluoroscopy
Transvenous cardiac pacing guided by ECG/ECHOPROCEDURE

Transvenous cardiac estimulation

ECG/ECHO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult males and females aged \> 18 years
  • symptomatic bradicardia
  • informed consent signed.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Coração - HMFMUSP

São Paulo, São Paulo, 05.417-000, Brazil

RECRUITING

Related Publications (3)

  • 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.

    PMID: 26880272RESULT

  • 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.

    PMID: 26539789RESULT

  • 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.

    PMID: 25829319RESULT

Related Links

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alexandre Soeiro, MD

    Unidade Clínica de Emergência

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Soeiro, MD

CONTACT

55-11-2661-5299alexandre.soeiro@bol.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 31, 2017

Study Start

August 16, 2017

Primary Completion

December 1, 2018

Study Completion

August 1, 2019

Last Updated

October 24, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)