An interventional study of Remote CIED Management in Arrhythmia, Cardiac, sponsored by Ratika Parkash. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-25.
Sponsored by Ratika Parkash · Not applicable, Interventional, and Other
Among 73 studies in Arrhythmias, Cardiac with a site in Canada — 13 open to participants now, 15 under way, none of them phase 3. Arrhythmias, Cardiac · Canada.
Among the 73 studies in Arrhythmias, Cardiac with a site in Canada, this one is the 29th largest by enrollment of the 49 interventional ones that give a count, is one of 3 that started in 2016, is one of 25 with no phase, and was the 40th registered.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
Browse Arrhythmias, Cardiac studies →13 of the 73 studies in Arrhythmias, Cardiac with a site in Canada are open now. Recruiting first, the newest first:
Cardurion Pharmaceuticals, Inc. · Sites in Canada, United States, France and 3 more countries
Ages 18–99
Novartis Pharmaceuticals · Sites in Canada, United States, China and 4 more countries
Ages 18+
Hamilton Health Sciences Corporation · Sites in Canada
Ages 18+
Myant Medical Corp. · Sites in Canada
Ages 18+
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Sites in Canada
Ages 18–80 · Healthy volunteers
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 167 Arrhythmias, Cardiac studies recruiting now, 118 (71%) set no upper age limit and 13 (8%) stop at 75 or younger; 31 take children under 18; 26 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
73 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 9 · Phase 3 13 · Phase 4 3
First in 1983; this study’s year is marked. 3 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 176 is above the median of 100 across 517 interventional studies indexed under Arrhythmias, Cardiac.
Median enrollment 240 across the 49 interventional studies, 172 across the 24 observational. Of the 53 that completed or were terminated, 13 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 73 have an industry lead sponsor. The 10 most frequent:
Ratika Parkash is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Ratika Parkash has 2 studies filed under Arrhythmias, Cardiac — fewer than ten, so there is no comparison to draw.
9 of the studies in Arrhythmias, Cardiac with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT04520347University of California, Los AngelesIVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry | 2026-12 |
| NCT05258422McGill University Health Centre/Research Institute of the McGill University Health CentreStereotactic Arrhythmia Radioablation for Ventricular Tachycardia (StAR-VT) | 2026-12-31 |
| NCT06164808HelpWear Inc.Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch | 2026-12-31 |
| NCT06174220Hamilton Health Sciences CorporationTargeted Therapy With Glycogen Synthase Kinase-3 Inhibition for Arrhythmogenic Cardiomyopathy | 2027-02-01 |
Add all 9 to your calendar (.ics) → With an account.
Among the 73 studies in Arrhythmias, Cardiac with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a pilot study to assess barriers, evaluate and implement a patient oriented CIED management model incorporating advanced technological innovation to promote a paradigm shift to patient-centered care involving remote CIED monitoring and programming. The advancement in technology is very important as it addresses several potential gaps and barriers in the care of patients with CIEDS:
Canada is a country with a diverse geography, of which 19% of the inhabitants are in communities classified as 'rural', but many may still have long distances to travel to reach a health care facility. This results in challenges in uniform delivery of health care throughout the country. There are 25,000 pacemaker (PM) implants and 7000 implantable defibrillator (ICD) implants yearly in Canada, with approximately 120 000 patients living with these devices. The recommended follow-up for these devices are based on consensus and position statements, with the majority of patients requiring at least yearly visits to a specialized device clinic during the lifetime of their device. 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.
While remote monitoring technology is currently available and has permitted surveillance and device assessment from any patient location accessible to a landline or mobile phone, the use has been inconsistent in Canada. In addition, new technology has become available that not only permits surveillance, but also remote programming of these devices. The incorporation of remote programming 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 and no longer require travel to the specialized 'hub' clinics for follow-up.
Inclusion Criteria:
Patients with a CIED will undergo remote monitoring with information technology.
Device: Remote CIED Management
Information Technology
Generalizability: Measurement of generalizability will be done by measuring the number of patients eligible for remote patient management as a proportion of all CIED patients.
Time frame: 6 months
Feasibility: Feasibility will be measured by the time to implement a fully functioning system at the participating centers
Time frame: 6 months
Compliance (number of received remote transmissions divided by the number of expected remote transmissions)
Compliance to remote patient management will be measured for patients by the number of received remote transmissions divided by the number of expected remote transmissions.
Time frame: 12 months
Plan to share: No
Ran from Oct 2016 to primary completion in Mar 2019, 29 months.
Of 171 non-industry interventional studies with no phase under Arrhythmias, Cardiac, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 43. This study's 29 months is close to that.
Counting every sponsor, half of 242 studies reached it within 24 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ratika Parkash