Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring

• Conditions: Tachycardia Bradycardia; Tachyarrhythmia; Bradyarrhythmia; Brady-tachy Syndrome; Bradycardia; Syncope; AVB - Atrioventricular Block
• Interventions: Procedure: Temporary transvenous cardiac pacing

• Registration Number: NCT04905199
• Lead Sponsor: Hunan Provincial People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-25
• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-27
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-19
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with indication of temporary transvenous pacing

Exclusion Criteria

• Not applicate to IC-ECG monitoring.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Floating catheter	Temporary transvenous cardiac pacing	When using floating catheter.
Non-floating catheter	Temporary transvenous cardiac pacing	When using non-floating catheter.

Primary Outcome Measures

Name	Time	Method
Pacer leads location	One day.	Satisfy location is in the apex of the right ventricle.
Catheter-related complications	One month.	Pacing catheter related complications: tip dislocation caused pacemaker malfunction, myocardial injury, perforation, death.

Secondary Outcome Measures

Name	Time	Method
Other complications	One month.	Complications not relate to pacing catheter.

Trial Locations

Locations (1)

Hunan Provincial People's hospital; 🇨🇳 Changsha, Hunan, China