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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04905199
Other study ID # 202084
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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.
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