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Clinical Trials/NCT04905199
NCT04905199
Unknown
Not Applicable

Bedside Precise Temporary Transvenous Cardiac Pacemaker Placement by Intracavitary Electrocardiogram Monitoring

Hunan Provincial People's Hospital1 site in 1 country60 target enrollmentMarch 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bradycardia; Syncope
Sponsor
Hunan Provincial People's Hospital
Enrollment
60
Locations
1
Primary Endpoint
Pacer leads location
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 25, 2021
End Date
January 31, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hunan Provincial People's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Meng Liu

Attending physician

Hunan Provincial People's Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with indication of temporary transvenous pacing

Exclusion Criteria

  • Not applicate to IC-ECG monitoring.

Outcomes

Primary Outcomes

Pacer leads location

Time Frame: One day.

Satisfy location is in the apex of the right ventricle.

Catheter-related complications

Time Frame: One month.

Pacing catheter related complications: tip dislocation caused pacemaker malfunction, myocardial injury, perforation, death.

Secondary Outcomes

  • Other complications(One month.)

Study Sites (1)

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