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Ultrasound Axillary Vein Access: Evaluation of Learning Curve for an Alternative Approach to Cardiac Device Implantation

NCT04382430 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-10-04

No results posted yet for this study

Summary

The purpose of this study is to determine the learning curve associated with Ultrasound (US) guided axillary vein access for cardiac device implantation based on length of procedure among operators of various levels of experience and to assess the 30-day complication rate for patients undergoing US guided device placement versus traditional implant methods.

Conditions

  • Ultrasound Therapy; Complications
  • Cardiac Device Implant
  • Venous Access

Interventions

PROCEDURE

Ultrasound guided venous access

Each physician/ provider will perform 2 assisted ultrasound (US) guided venous access and pocket creation for cardiac device implant and 10 solo ultrasound guided cardiac device implant.

PROCEDURE

Conventional technique

Physician will perform 5 cardiac device implant using conventional technique of venous access and pocket creation

Sponsors & Collaborators

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Seth Sheldon, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-28
Primary Completion
2021-06-06
Completion
2021-06-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04382430 on ClinicalTrials.gov