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ConfirmRxTM: Posture and Activity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803969
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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.

Condition or disease Intervention/treatment Phase
Syncope Cryptogenic Stroke Device: ConfirmRx (Insertable Cardiac Monitor) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a prospective, single arm, unblinded, non-randomized, open-label, multi-center, post-market clinical investigation.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: ConfirmRxTM: Effects of Patient Posture and Physical Activity
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803969


Contacts
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Contact: Sinny Delacroix, MD, PhD 61 8 8202 6651 sinny.delacroix@abbott.com
Contact: Luke C McSpadden, PhD +1 818 493 3720 luke.mcspadden@abbott.com

Locations
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Australia, Queensland
The Wesley Hospital Recruiting
Auchenflower, Queensland, Australia, 4066
Contact: Sonia Nelson    61 7 3858 8918    sonia.nelson@genesiscare.com   
Principal Investigator: Stephen Pavia         
Friendly Society Private Hospital Recruiting
Bundaberg, Queensland, Australia, 4670
Contact: Kassandra Howes    61 7 4199 7300    kassandra.howes@genesiscare.com   
Principal Investigator: Andre Conradie         
Greenslopes Private Hospital Recruiting
Greenslopes, Queensland, Australia, 4120
Contact: Sonia Nelson    61 7 3858 8918    sonia.nelson@genesiscare.com   
Principal Investigator: Anders Taylor         
Australia, South Australia
St Andrews Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Renae Deans, MD, PhD    61 8 8202 6654    renae.deans@genesiscare.com   
Principal Investigator: Glenn Young         
Australia, Victoria
Warringal Private Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Michelle Ord    61 3 8467 5900    michelle.ord@genesiscare.com   
Principal Investigator: David O'Donnell         
The Valley Private Hospital Not yet recruiting
Mulgrave, Victoria, Australia, 3170
Contact: Michelle Ord    61 3 8467 5900    michelle.ord@genesiscare.com   
Sub-Investigator: Matthew Swale         
Australia, Western Australia
St John of God Murdoch Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
Contact: Joy Vibert    61 8 9400 6232    joy.vibert@genesiscare.com   
Principal Investigator: Vincent Paul         
Mount Hospital Recruiting
Perth, Western Australia, Australia, 6000
Contact: Joy Vibert    61 8 9400 6232    joy.vibert@genesiscare.com   
Principal Investigator: Benjamin King         
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Stephen Pavia, MBBS, FRACP Fundacion GenesisCare
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03803969    
Other Study ID Numbers: ABT-CIP-10250 Ver. A.1
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abbott Medical Devices:
Syncope
Cryptogenic Stroke
Physical activity
Posture
Additional relevant MeSH terms:
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Syncope
Nervous System Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations