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Pacertool Early Feasibility Study - Safety and Performance

NCT06103539 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-10-26

No results posted yet for this study

Summary

The study is a non-randomized, two-part, open label, prospective single-site, single arm, safety and performance study. The study is designed to collect acute and long-term clinical data and user reported outcome data from using the PreSens-Catheter and PACER Software during cardiac catheterization and Cardiac Resynchronization Therapy (CRT) device implantation procedures. Subjects with indication for arterial catheterization and CRT will be included.

Conditions

  • Heart Failure With Reduced Ejection Fraction
  • Dyssynchrony
  • Medical Device Performance

Interventions

DEVICE

Cardiac catheterization and evoked response to cardiac stimulation

Cardiac catheterization with a combined elecrtophysiology and pressure sensing catheter to perform multisite stimulation and measure the evoked pressure response in a connected software.

Sponsors & Collaborators

  • Pacertool AS

    lead INDUSTRY

Principal Investigators

  • Tamaz Shaburishvili, MD · Tbilisi Heart and Vascular Clinic

Eligibility

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

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-09-01
Completion
2024-12-30

Countries

  • Georgia

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 NCT06103539 on ClinicalTrials.gov