ConfirmRxTM: Posture and Activity

NCT03803969 | Completed

• 1 other identifier: ABT-CIP-10250 Ver. A.1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

Syncope; Cryptogenic Stroke; Physical activity; Posture

Outcome Measures

Primary Outcomes (1)

• Characterisation of the safety and performance of Confirm Rx™ with changes in posture and physical activity at implant and 30days 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 Outcomes (1)

• Identification of any gross migration of Confirm Rx device 30 days following implant

  30+15 days post procedure

Study Arms (1)

ConfirmRx (Insertable Cardiac Monitor)

OTHER

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)

Interventions

ConfirmRx (Insertable Cardiac Monitor) DEVICE

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.

ConfirmRx (Insertable Cardiac Monitor)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients will meet all the following:
• Subjects are 18 years of age or older, or of legal age to give informed consent specific to state and national law.
• Subject must provide written informed consent prior to any clinical investigation related procedure.
• Have an approved indication for continuous arrhythmia monitoring with an Insertable Cardiac Monitor.
• Should be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
• 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.

You may not qualify if:

• Patients will be excluded if they meet any of the following:
• Subject has previously received an Insertable Cardiac Monitor.
• 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.
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (8)

The Wesley Hospital

Auchenflower, Queensland, 4066, Australia

Location

Friendly Society Private Hospital

Bundaberg, Queensland, 4670, Australia

Location

Greenslopes Private Hospital

Greenslopes, Queensland, 4120, Australia

Location

St Andrews Hospital

Adelaide, South Australia, 5000, Australia

Location

Warringal Private Hospital

Heidelberg, Victoria, 3084, Australia

Location

The Valley Private Hospital

Mulgrave, Victoria, 3170, Australia

Location

St John of God Murdoch Hospital

Murdoch, Western Australia, 6150, Australia

Location

Mount Hospital

Perth, Western Australia, 6000, Australia

Location

Related Publications (1)

• Swale M, Paul V, Delacroix S, Young G, McSpadden L, Ryu K, Di Fiore D, Santos M, Tan I, Conradie A, Duong M, Schwarz N, Worthley S, Pavia S. Changes in R-wave amplitude at implantation are associated with gender and orientation of insertable cardiac monitor: observations from the confirm Rx body posture and physical activity study. BMC Cardiovasc Disord. 2022 Oct 8;22(1):439. doi: 10.1186/s12872-022-02752-0.

  PMID: 36209063 DERIVED

MeSH Terms

Conditions

Syncope; Ischemic Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Stephen Pavia, MBBS, FRACP

  Fundacion GenesisCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, single arm, unblinded, non-randomized, open-label, multi-center, post-market clinical investigation.

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 15, 2019
• Study Start: October 30, 2018
• Primary Completion: May 30, 2020
• Study Completion: July 30, 2020
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (8)