Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring

Tachyarrhythmia Clinical Trial

Official title:

Bedside Precise Temporary Transvenous Cardiac Pacemaker Placement by Intracavitary Electrocardiogram Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04905199
• Other study ID #: 202084
• Status: Recruiting
• Start date: March 25, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: November 2021
• Source: Hunan Provincial People's Hospital
• Contact: Meng Liu, MD
• Phone: +8615084858606
• Email: 183578012[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Traditional temporary pacing catheter insertion by intracavitary electrocardiogram (IC-ECG) monitoring which only monitoring tip polar, the negative one. The investigators modified the technique by monitoring both negative and positive polar which will be precisely locating catheter tip and indicating the direction of the catheter tip.

Extensively used temporary pacing catheter tip has two electrodes which are about 1 cm apart. Distal electrode is negative (-) and active, proximal electrode is positive (+) and indifferent.

Investigators use both distal (-) and proximal (+) electrodes which can be attached to any two of the V leads, record as V(-) and V(+). Monitoring positions of the electrodes by V(-) and V(+) could provide more information about the tip position. Comparing the QRS amplitudes between V(-) and V(+), when catheter tip enters right ventricle chamber: the case of V(-) > V(+) infers tip toward apex ventricle wall ; conversely, the case of V(-)<V(+) indicates tip directs to outflow tract.

The investigators hypothesis this monitoring will help precisely placement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Patients with indication of temporary transvenous pacing

Exclusion Criteria:

• Not applicate to IC-ECG monitoring.

Related Conditions & MeSH terms

• Atrioventricular Block
• AVB - Atrioventricular Block
• Brady-tachy Syndrome
• Bradyarrhythmia
• Bradycardia
• Syncope
• Tachyarrhythmia
• Tachycardia

Intervention

Procedure:
• Temporary transvenous cardiac pacing
Transvenous temporary pacemaker insertion by modified IC-ECG monitoring.

Locations

Country	Name	City	State
China	Hunan Provincial People's hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pacer leads location	Satisfy location is in the apex of the right ventricle.	One day.
Primary	Catheter-related complications	Pacing catheter related complications: tip dislocation caused pacemaker malfunction, myocardial injury, perforation, death.	One month.
Secondary	Other complications	Complications not relate to pacing catheter.	One month.