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ConfirmRxTM: Posture and Activity

NCT03803969 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-14

No results posted yet for this study

Summary

Insertable Cardiac Monitor's (ICM's) such as Confirm Rx™ are leadless devices implanted for long-term heart rhythm monitoring in the diagnosis and management of clinical conditions such as recurrent unexplained syncope, cryptogenic stroke, ventricular arrhythmias and monitoring atrial fibrillations (AF) post ablation. There is limited data on variations seen in signal sensing with changes in physical activity and posture. This single arm, non-randomized, open-label, multi-center, clinical investigation of 100 subjects is designed to characterise the safety and performance of Confirm RxTM by assessing quality of signal attained from the device with changes in posture and physical activity at implant and 30days post procedure. The study is also intended to assess gross migrations of the device at 30days post implant.

Conditions

  • Syncope
  • Cryptogenic Stroke

Interventions

DEVICE

ConfirmRx (Insertable Cardiac Monitor)

This study is designed to characterise the safety and performance of the ConfirmRx device by assessing quality of signal attained from the device with changes in posture and physical activity at implant and 30days post procedure. The study is also intended to assess gross migrations of the device at 30days post implant.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Stephen Pavia, MBBS, FRACP · Fundacion GenesisCare

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-30
Primary Completion
2020-05-30
Completion
2020-07-30

Countries

  • Australia

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 NCT03803969 on ClinicalTrials.gov