Arrhythmia, Cardiac Clinical Trial
Official title:
Remote Patient Management for Cardiac Implantable Electronic Devices - A Pilot Study
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:
1. Long, expensive travel for patients
2. Morbidity to patients due to delay in receiving appropriate treatment
3. Efficiency in health care delivery
4. Patient satisfaction
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05563701 -
Evaluation of the LVivo Image Quality Scoring (IQS)
|
||
Recruiting |
NCT02988219 -
Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
|
Phase 4 | |
Suspended |
NCT03647891 -
Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized Cardiac Patients
|
N/A | |
Recruiting |
NCT04345627 -
Japanese Lead Extraction Registry
|
||
Completed |
NCT04076020 -
Atrial Fibrillation Health Literacy and Information Technology Trial in Rural Pennsylvania Counties
|
N/A | |
Terminated |
NCT03035227 -
Catheter Ablation of Arrhythmias to Improve CRT Response
|
Phase 4 | |
Completed |
NCT02991716 -
Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development
|
N/A | |
Completed |
NCT03150030 -
Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes
|
||
Recruiting |
NCT05437926 -
A Study to Describe the Effectiveness of Arrhythmia Analysis Software for Screening of Sinus Rhythm, Atrial Fibrillation and Premature Beats in light-and Dark Skin Tone Patients
|
||
Completed |
NCT01956487 -
Bioequivalence of RYTHMOL SR® Manufactured at Two Different Sites
|
Phase 1 |