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AtaCor Subcostal Temporary Extravascular Pacing III Study

NCT04538287 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-07-07

No results posted yet for this study

Summary

Third in-human study for the AtaCor Extravascular (EV) Temporary Pacing Lead System to collect initial safety and performance data for the latest AtaCor System.

The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System 1) to support the development a future pivotal study with an indication limited to a maximum of 7 days, and 2) to obtain early clinical data for future research related to longer-term use.

Conditions

  • Conduction Defect

Interventions

DEVICE

AtaCor StealthTrac Lead

Subjects are assigned non-randomly to receive one of the four AtaCor StealthTrac leads being evaluated in the study.

Sponsors & Collaborators

  • AtaCor Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin C Burke, DO · AtaCor Medical, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-03
Primary Completion
2022-01-25
Completion
2022-05-11

Countries

  • Czechia
  • New Zealand
  • Paraguay

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 NCT04538287 on ClinicalTrials.gov