- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03405740
Remote Patient Management of CIEDs (RPM CIED Tachy)
Remote Patient Management of Cardiac Implantable Electronic Devices - Tachy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Remote monitoring (RM) has been in use for over a decade and is now used in a blended system of in clinic visits and RM to provide CIED follow up. Prior studies have focused on this blended model of follow up. In this study, we propose a paradigm shift in CIED follow up care that is fully remote, supported by a patient-centered communication system permitting patients to have greater understanding of their CIED and its function. Patients would not have to leave their own communities to obtain state-of-the art care for their cardiac condition or their CIED. Given the burgeoning use of CIEDs (ICDs and PMs), the aging population and particularly in Canada where 19% of the inhabitants are in communities classified as 'rural', many have long distances to travel to reach a health care facility, it is of the utmost importance to take full advantage of available and developing technologies to improve CIED follow up beyond current recommendations. During the life of these patients, many issues may arise, such as atrial or ventricular arrhythmias that may result in syncope, stroke or sudden death, need for increased monitoring resulting from device advisories, or minor programming adjustments to improve device performance, or simply the need for enhanced surveillance as the device battery depletes and replacement is anticipated. New technology has become available that not only permits surveillance, but also permits communication back to the patient, and their respective providers regarding the status of these devices. The combination of technologies will result in a total care of CIEDs termed Remote Patient Management - CIED (RPM-CIED). The incorporation of enhanced monitoring capability, along with automatic recalibration of device settings, allows us to develop a new paradigm of remote patient management where after the patient receives their device, they would remain in the care of their local health team ('spokes') and no longer require travel to the specialized device clinics ('hubs') for follow-up. It creates capacity in the specialized centers to focus exclusively on the problematic cases by removing the need for routine checks.
There are two avenues of new technology that will be used in this study:
- Remote View: this secure, web-based portal facilitates a virtual view of the device programming by the specialist in real-time while the patient is in their local clinic, thus avoiding patient travel to the specialized clinic (hub).
- VIRTUES (Virtual Integrated Reliable Transformative User-driven E-health System): this portal has been developed by the Cardiac Arrhythmia Network of Canada to allow the patient to receive reports from the remote transmissions of their device.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ratika Parkash, MD FRCPC
- Phone Number: 902 473 4474
- Email: ratika.parkash@nshealth.ca
Study Contact Backup
- Name: Karen Giddens
- Phone Number: 902 473 2758
- Email: karen.giddens@nshealth.ca
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada
- Recruiting
- Foothills Hospital
-
Contact:
- Marcello Tonelli
-
Principal Investigator:
- Satish Raj, MD, FRCPC
-
-
Manitoba
-
Winnipeg, Manitoba, Canada
- Not yet recruiting
- St. Boniface Hospital
-
Contact:
- Rebecca Fromm
-
Principal Investigator:
- Clarence Khoo, MD, FRCPC
-
-
New Brunswick
-
Saint John, New Brunswick, Canada
- Recruiting
- Saint John Regional Hospital
-
Contact:
- Jessica Gallager
-
Principal Investigator:
- Satish Toal, MBBS, FRCPC
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 3A7
- Recruiting
- QEII HSC
-
Contact:
- Jennifer Thurlow
- Phone Number: 902 473-4841
- Email: jennifer.thurlow@nshealth.ca
-
Principal Investigator:
- Amir AbdelWahab, MBBCh MSc MD
-
-
Ontario
-
Kitchener, Ontario, Canada
- Recruiting
- St. Mary's General Hospital
-
Contact:
- Mary Radyk
-
Principal Investigator:
- Umjeet Jolly, MD, FRCPC
-
London, Ontario, Canada
- Not yet recruiting
- London Health Sciences Center
-
Contact:
- Cheryl Litchfield
-
Principal Investigator:
- Anthony Tang, MD, FRCPC
-
-
Quebec
-
Montreal, Quebec, Canada
- Recruiting
- Hopital SacreCoeur
-
Contact:
- Ann Langlois
-
Principal Investigator:
- Marcio Sturmer, MD, FRCPC
-
Québec, Quebec, Canada, G1V 4G5
- Recruiting
- Hôpital Laval
-
Contact:
- Paule Banville
- Phone Number: 418-656-8711 ext : 2132
- Email: paule.banville@criucpq.ulaval.ca
-
Principal Investigator:
- Isabelle Nault, MD FRCPC
-
Sherbrooke, Quebec, Canada, J1H 5N4
- Recruiting
- Centre Hospitalier Universitaire de Sherbrooke
-
Principal Investigator:
- Félix Ayala-Paredes, MD
-
Contact:
- Stephanie McMahon
- Phone Number: 1 844 721-6094
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medtronic or Abbott defibrillator (ICD or CRT-D) capable of remote monitoring with Carelink/Merlin
- Able to provide consent
Exclusion Criteria:
- No family physician
- Inability to be referred to a specialist
- Currently followed more than every 6 months by a Heart Function Clinic
- Participation in another randomized clinical trial
- Unreliable autocapture by device in pacemaker dependent patient
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Remote Patient Management
Patients will be followed by remote monitoring only.
|
|
Placebo Comparator: Standard of Care
Remote monitoring at 6 month intervals, alternating with yearly in-clinic visits at their usual site.
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to major adverse cardiac event (primary safety outcome)
Time Frame: 18 months
|
Time to a major adverse event, including: death, stroke, hospitalization for complications relating to the device system, cardiovascular hospitalization, syncope, device-related Emergency Department visits.
|
18 months
|
Time to a device-detected event
Time Frame: 18 months
|
The response time from a clinical event to a clinical decision in response to arrhythmias, cardiovascular disease progression, and device issues with remote patient management as compared to standard of care
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to detection of ventricular arrhythmia events
Time Frame: 18 months
|
device-detected ventricular fibrillation or ventricular tachycardia
|
18 months
|
Detection of atrial fibrillation episodes
Time Frame: 18 months
|
Device detected episodes of atrial fibrillation
|
18 months
|
Atrial fibrillation related hospitalizations
Time Frame: 18 months
|
Hospitalization with a primary diagnosis of atrial fibrillation
|
18 months
|
Time to syncope
Time Frame: 18 months
|
Syncope
|
18 months
|
Cost effectiveness
Time Frame: 18 months
|
An economic evaluation will include a cost utility analysis
|
18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ratika Parkash, MD FRCPC, Nova Scotia Health Authority
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RP005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cardiac Arrhythmia
-
Medical University of LodzNot yet recruitingCardiac Arrhythmia | Supraventricular ArrhythmiaPoland
-
Myant Medical Corp.Partners in Advanced Cardiac EvaluationCompleted
-
New York Institute of TechnologyCompleted
-
Kansas City Heart Rhythm InstituteBiosense Webster, Inc.TerminatedArrhythmia, CardiacUnited States
-
Children's National Research InstituteNational Institutes of Health (NIH)CompletedVentricular Tachycardia | Cardiac ArrhythmiaUnited States
-
SanofiCompletedVentricular Arrhythmia | Arrhythmia ProphylaxisNetherlands, Spain, Belgium, Japan, Finland, Chile, Australia, United States, Argentina, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Mexico, Norway, Poland, Portugal, Russian Federation, Slovakia, South Africa and more
-
Ruiqin xieCompletedSlow Arrhythmia; Left Bundle Branch Pacing; Cardiac FunctionChina
-
Adana City Training and Research HospitalCompleted
-
University of California, San DiegoCompletedAtrioventricular Block | Cardiac Arrhythmia | Sick Sinus Syndrome | Symptomatic BradycardiaUnited States
-
Huawei Device Co., LtdRecruiting
Clinical Trials on Remote Patient Management
-
Northwestern UniversityOmron Healthcare Co., Ltd.Completed
-
Charite University, Berlin, GermanyGerman Federal Ministry of Education and Research; University of LeipzigCompleted
-
University of Alabama at BirminghamNational Institute on Minority Health and Health Disparities (NIMHD)Not yet recruitingType 2 Diabetes
-
University of Mississippi Medical CenterHealth Resources and Services Administration (HRSA)Completed
-
University of British ColumbiaCompleted
-
Tracy Jalbuena MDHealth Resources and Services Administration (HRSA); MaineHealthWithdrawnDiabetes Mellitus, Type 2United States
-
Columbia UniversityNew York Presbyterian Hospital; Philips HealthcareCompleted
-
Charite University, Berlin, GermanyCompletedRemote Patient Monitoring on Intensive Care UnitGermany
-
University of California, DavisCompletedType 1 DiabetesUnited States
-
Ratika ParkashMedtronic; Cardiac Arrhythmia Network of CanadaCompletedArrhythmia, CardiacCanada