ConfirmRxTM: Posture and Activity

January 8, 2024 updated by: Abbott Medical Devices

ConfirmRxTM: Effects of Patient Posture and Physical Activity

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Syncope is a condition that has vexed cardiologists worldwide due to its elusive nature. Often a third of patients with syncope remain undiagnosed despite assessments by multidisciplinary teams and the availability of various screening techniques such as electrocardiography, 24-h Holter monitoring, carotid sinus massage, echocardiography, exercise testing, head-up tilt test, and electrophysiological studies. Recently, ICM's have been developed to continuously monitor heart rhythm and thus aid in the diagnoses and management of clinical conditions such as ventricular arrhythmias, cryptogenic stroke, recurrent unexplained syncope and for monitoring atrial fibrillations (AF) post ablation. ICM's such as Confirm Rx from Abbott are leadless devices that detect arrhythmias largely depending on sensing of changes in R-R interval and R wave amplitude in the ECG signal. Whilst ICM's have been helpful in detecting arrhythmias in up to 40% of these patients with unexplained syncope, there is paucity of data regarding changes in signal quality with variations in body posture, physical activity and device movements that could potentially have effects on ECG signal and thus event detection. To this extent, this is an Abbott sponsored prospective, single arm, non-randomized, open-label, multi-center, clinical trial of 100 subjects designed to characterize the safety and performance of Confirm Rx™ in relation to physical activity and posture in these subjects with unexplained syncope.

ConfirmRx™ has come a long way since its inception with a significant reduction in size (78% reduction by volume) that has led to relatively simple insertion procedures through a small skin incision. The less complicated insertion process permits the insertion procedure to take place in settings besides operating rooms and furthermore, smaller devices are associated with significantly lower incidence of infections. We believe that this study will add to growing body of evidence of the efficacy of ConfirmRx.

The primary objective of this clinical investigation is to characterise the safety and performance of the Confirm Rx™ Insertable Cardiac Monitor (ICM) by assessing quality of signal attained from device post implant with changes in posture and physical activity at implant and 30days post procedure.

Primary Endpoints

  • Changes in R-wave amplitudes at time of insertion and 30 days post-insertion.
  • Changes in R-wave amplitude with below defined movements at time of insertion, and 30days post-insertion.

To identify any gross migration of Confirm Rx device 30 days following implant. Secondary Endpoints

  • Change in measured distance/position of scar relative to distance from left lateral sternal border at baseline and 30 days
  • Measurement of tip of device from left lateral sternal border
  • Deviation of proximal tip of device from scar compared to baseline

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Recruiting
        • The Wesley Hospital
        • Contact:
        • Principal Investigator:
          • Stephen Pavia
      • Bundaberg, Queensland, Australia, 4670
        • Recruiting
        • Friendly Society Private Hospital
        • Contact:
        • Principal Investigator:
          • Andre Conradie
      • Greenslopes, Queensland, Australia, 4120
        • Recruiting
        • Greenslopes Private Hospital
        • Contact:
        • Principal Investigator:
          • Anders Taylor
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • St Andrews Hospital
        • Contact:
        • Principal Investigator:
          • Glenn Young
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Warringal Private Hospital
        • Contact:
        • Principal Investigator:
          • David O'Donnell
      • Mulgrave, Victoria, Australia, 3170
        • Not yet recruiting
        • The Valley Private Hospital
        • Contact:
        • Sub-Investigator:
          • Matthew Swale
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • St John of God Murdoch Hospital
        • Contact:
        • Principal Investigator:
          • Vincent Paul
      • Perth, Western Australia, Australia, 6000
        • Recruiting
        • Mount Hospital
        • Contact:
        • Principal Investigator:
          • Benjamin King

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Eligible patients will meet all the following:

  1. Subjects are 18 years of age or older, or of legal age to give informed consent specific to state and national law.
  2. Subject must provide written informed consent prior to any clinical investigation related procedure.
  3. Have an approved indication for continuous arrhythmia monitoring with an Insertable Cardiac Monitor.
  4. Should be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
  5. Female subjects of child-bearing potential should have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Exclusion Criteria:

Patients will be excluded if they meet any of the following:

  1. Subject has previously received an Insertable Cardiac Monitor.
  2. Subject is currently enrolled or intend to participate in another clinical investigation, which could confound the results of this trial during this clinical study as determined by the sponsor.
  3. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
  4. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ConfirmRx (Insertable Cardiac Monitor)
This is a single arm study where in patients with an approved indication for a cardiac monitor will receive a ConfirmRx Device.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterisation of the safety and performance of Confirm Rx™ with changes in posture and physical activity at implant and 30days post procedure
Time Frame: 30+15 days post procedure
Patient performs defined movements post insertion of device and assessments are made on the Merlin Programmer. These are repeated 30+15 days post procedure
30+15 days post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of any gross migration of Confirm Rx device 30 days following implant
Time Frame: 30+15 days post procedure
Measurements of location of the device is recorded post procedure and then measured again 30+15 days post procedure
30+15 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Stephen Pavia, MBBS, FRACP, Fundacion GenesisCare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2018

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10250 Ver. A.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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