BradycardiaEMERG-TV-PACNCT03037333
Analysis in the EMERGEncy Between TransVenous Cardiac PACIng Guided by Fluoroscopy Versus Echocardiogram
A study testing Transvenous cardiac pacing guided by fluoroscopy and Transvenous cardiac pacing guided by ECG/ECHO in people with Bradycardia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- Transvenous cardiac pacing guided by fluoroscopy and Transvenous cardiac pacing guided by ECG/ECHO
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Aug 2017to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult males and females aged > 18 years
- symptomatic bradicardia
- informed consent signed.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração - HMFMUSP
São Paulo, São Paulo, 05.417-000
Alexandre Soeiro, MD, 5511-2661-5299, alexandre.soeiro@bol.com.br
About this study
Official title: Prospective Analysis in the EMERGEncy Between TransVenous Cardiac PACIng Guided by Fluoroscopy Versus Echocardiogram
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.
Read the 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.
- Conditions
- Bradycardia
- Being tested
- Transvenous cardiac pacing guided by fluoroscopy, Transvenous cardiac pacing guided by ECG/ECHO
- Keywords
- echocardiogram, Electrocardiogram: Electrical Alternans, fluoroscopy
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvenous cardiac pacing guided by fluoroscopyProcedure or surgery
Transvenous cardiac estimulation
Transvenous cardiac pacing guided by ECG/ECHOProcedure or surgery
Transvenous cardiac estimulation
| Study group | Role | What they receive |
|---|---|---|
| fluoroscopy | Other | Not described Receives: Procedure: Transvenous cardiac pacing guided by fluoroscopy |
| ECG/ECHO | Other | Not described Receives: Procedure: Transvenous cardiac pacing guided by ECG/ECHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 1 week
infection
Incidence of infection assessed by a clinical diagnosis
Measured: 1 week
hematoma > 5 cm
image
Measured: 1 week
cardiac perforation
Incidence of cardiac perforation assessed by a clinical diagnosis
Measured: 1 week
pneumothorax
Incidence of pneumothorax assessed by a clinical diagnosis
Measured: 1 week
ventricular tachycardia
Incidence of ventricular tachycardia assessed by an ECG test
Measured: 1 week
loss of capture
Incidence of loss of capture assessed by an ECG test
Measured: 1 week
venous thrombosis
Incidence of venous thrombosis assessed by an ultrasound
Measured: 1 week
any complication the delays definitive pacemaker > 48 hours
clinical diagnosis
Measured: 1 week
Secondary outcomes (2)
Time to start the correct cardiac stimulation with transvenous pacing
minutes scale
Measured: 1 week
rates of success
ECG test
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start16 Aug 2017
- Primary completionDec 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Soeiro, MD, Principal investigator, Unidade Clínica de Emergência
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037333
- Sponsor's protocol ID
- PSInCor-EMERG-TV-PAC
- Acronym
- EMERG-TV-PAC
- Status last verified
- Oct 2018
- First submitted
- 18 Jan 2017
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26880272Reusz 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.
PubMed 26539789Bouaziz 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.
PubMed 25829319
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis in the EMERGEncy Between TransVenous Cardiac PACIng Guided by Fluoroscopy Versus Echocardiogram
- ClinicalTrials.gov ID
- NCT03037333
- Acronym / sponsor ID
- EMERG-TV-PAC / PSInCor-EMERG-TV-PAC
- Conditions
- Bradycardia
- Keywords
- echocardiogram, Electrocardiogram: Electrical Alternans, fluoroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluoroscopy | Other | Procedure: Transvenous cardiac pacing guided by fluoroscopy |
| ECG/ECHO | Other | Procedure: Transvenous cardiac pacing guided by ECG/ECHO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult males and females aged > 18 years
- symptomatic bradicardia
- informed consent signed.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvenous cardiac pacing guided by fluoroscopyTransvenous cardiac estimulation | Procedure or surgery | fluoroscopy |
| Transvenous cardiac pacing guided by ECG/ECHOTransvenous cardiac estimulation | Procedure or surgery | ECG/ECHO |
Primary outcome
all cause mortality
Time frame: 1 week
infection
Time frame: 1 week
Incidence of infection assessed by a clinical diagnosis
hematoma > 5 cm
Time frame: 1 week
image
cardiac perforation
Time frame: 1 week
Incidence of cardiac perforation assessed by a clinical diagnosis
pneumothorax
Time frame: 1 week
Incidence of pneumothorax assessed by a clinical diagnosis
ventricular tachycardia
Time frame: 1 week
Incidence of ventricular tachycardia assessed by an ECG test
loss of capture
Time frame: 1 week
Incidence of loss of capture assessed by an ECG test
venous thrombosis
Time frame: 1 week
Incidence of venous thrombosis assessed by an ultrasound
any complication the delays definitive pacemaker > 48 hours
Time frame: 1 week
clinical diagnosis
2 secondary outcomes
Time to start the correct cardiac stimulation with transvenous pacing
Time frame: 1 week
rates of success
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Results publication: PubMed 26880272Esmaiel 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 publication: PubMed 26539789Reusz 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 publication: PubMed 25829319Bouaziz 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Soeiro, MD principal investigator
Unidade Clínica de Emergência
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvenous cardiac pacing guided by fluoroscopy and Transvenous cardiac pacing guided by ECG/ECHO in people with Bradycardia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Soeiro, MD (55-11-2661-5299 ext. 4061, alexandre.soeiro@bol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 1 week). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03037333, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.