Tachyarrhythmia Clinical Trial
Official title:
Bedside Precise Temporary Transvenous Cardiac Pacemaker Placement by Intracavitary Electrocardiogram Monitoring
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Hunan Provincial People's hospital | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
Hunan Provincial People's Hospital |
China,
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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