Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring

Bedside Precise Temporary Transvenous Cardiac Pacemaker Placement by Intracavitary Electrocardiogram Monitoring

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.

Study Overview

• Status: Recruiting
• Conditions: Tachyarrhythmia; Brady-tachy Syndrome; Bradyarrhythmia; Bradycardia; Syncope; AVB - Atrioventricular Block; Tachycardia Bradycardia
• Intervention / Treatment: Procedure: Temporary transvenous cardiac pacing

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Meng Liu, MD; Phone Number: +8615084858606; Email: 183578012@qq.com
• Study Contact Backup: Name: Xiaotong Han, MD; Phone Number: +8613725870299; Email: 744953695@qq.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Hunan Provincial People's Hospital
      • Contact: Jie Zhong, MD; Phone Number: +8673182278047; Email: kybgcp@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients need emergency or selective temporary pacing.

Description

Inclusion Criteria:

• Patients with indication of temporary transvenous pacing

Exclusion Criteria:

• Not applicate to IC-ECG monitoring.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-floating catheter; When using non-floating catheter.	Procedure: Temporary transvenous cardiac pacing; Transvenous temporary pacemaker insertion by modified IC-ECG monitoring.
Floating catheter; When using floating catheter.	Procedure: Temporary transvenous cardiac pacing; Transvenous temporary pacemaker insertion by modified IC-ECG monitoring.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other complications	Complications not relate to pacing catheter.	One month.

Collaborators and Investigators

• Sponsor: Hunan Provincial People's Hospital
• Investigators: Study Director: Xiaotong Han, MD, Hunan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 25, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): January 31, 2022

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (ACTUAL): May 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Unconsciousness; Consciousness Disorders; Heart Block; Bradycardia; Tachycardia; Syncope; Atrioventricular Block
• Other Study ID Numbers: 202084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Any date will share if appropriate.
• IPD Sharing Time Frame: Two years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No