Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring

NCT04905199 | Unknown

• 1 other identifier: 202084
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bradycardia; Syncope; Bradyarrhythmia; Brady-tachy Syndrome; Tachycardia Bradycardia; AVB - Atrioventricular Block; Tachyarrhythmia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Other complications

  One month.

Study Arms (2)

Non-floating catheter

When using non-floating catheter.

Procedure: Temporary transvenous cardiac pacing

Floating catheter

When using floating catheter.

Procedure: Temporary transvenous cardiac pacing

Interventions

Temporary transvenous cardiac pacing PROCEDURE

Transvenous temporary pacemaker insertion by modified IC-ECG monitoring.

Floating catheter; Non-floating catheter

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients need emergency or selective temporary pacing.

You may qualify if:

• Patients with indication of temporary transvenous pacing

You may not qualify if:

• Not applicate to IC-ECG monitoring.

Sponsors & Collaborators

• Hunan Provincial People's Hospital: lead

Study Sites (1)

Hunan Provincial People's hospital

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Bradycardia; Syncope; Atrioventricular Block; Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Heart Block; Cardiac Conduction System Disease

Study Officials

• Xiaotong Han, MD

  Hunan Provincial People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Meng Liu, MD

CONTACT

+8615084858606; 183578012@qq.com

Xiaotong Han, MD

CONTACT

+8613725870299; 744953695@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 27, 2021
• Study Start: March 25, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Two years.

Locations

CN (1)