Clinical trial NCT03810820: Remote ECG Monitoring of TAVI Patients
Official title: Remote ECG Monitoring to Reduce Complications Following Transcatheter Aortic Valve Implantations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Valve Disease
Aortic Valve Stenosis
Keywords: TAVR
TAVI
Heart block
Atrial fibrillation
Cardiac arrhythmias
Permanent pacemaker
Remote cardiac monitoring
Loop monitor
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
name: Southlake Regional Health Centre
name: Sunnybrook Health Sciences Centre
name: M-Health Solutions
First posted: 2019-01-22
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort of consecutive patients booked for outpatient TAVI.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: After surgery, patients who undergo transcatheter aortic valve implantation (TAVI) are at risk of developing cardiac arrhythmias such as heart blocks and atrial fibrillation. Current practice is to monitor TAVI patients in hospital for 2-8 days post procedure using scarce and expensive hospital telemetry beds. This study will use a new monitoring service called mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS) to risk stratify patient pre-TAVI and provide an added layer of monitoring that would support earlier discharge of suitably identified patients 24-hours post TAVI. The study will assess whether this strategy will significantly reduce the pressure on hospital resources while improving patient outcomes and experience.

Detailed description: Aortic stenosis (AS), the most common valvular heart disease, occurs when there is a narrowing of the aortic valve opening. New transcatheter aortic valve implantation (TAVI, also called transcatheter aortic valve replacement \[TAVR\]), is a minimally invasive surgical procedure that is rapidly expanding as the dominant treatment modality for elderly patients with AS. Approximately 1000 patients will undergo TAVR surgery in Ontario in fiscal year 2018-2019 and that number is expected to increase to \~80% of all valve replacement surgery within the next 5 years.

Patients that undergo TAVI are at risk of developing cardiac arrhythmias such as heart block and atrial fibrillation and many are routinely monitored in-hospital for 5-8 days post-surgery. Currently, this monitoring is done using scarce and expensive hospital telemetry beds.

This study uses a novel clinical pathway including remote monitoring pre- and post-TAVI using a new service called mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS™). m-CARDS™ consists of a patient cardiac monitoring device that transmits cardiac data in real time to a centralized center. Patients wearing the device can remain in the comfort of their own home while being monitored remotely. The monitoring device is Health Canada approved and has been used extensively. Because it is highly sensitive to cardiac arrhythmias, including all levels of heart block, it is ideally suited for this type of monitoring.

If this pathway is adopted across all centres it will significantly reduce the pressure on hospital resources while at the same time improve the patient experience, enabling them to get home sooner. Hospital telemetry is very expensive. Reducing the length of stay from 2-8 days on average to 24hr for many patients would represent cost savings to the hospitals and province.

While some studies show that patients could be discharged earlier, there is still significant variability in adopting a short length of stay post-TAVI due to a perceived need for inpatient monitoring and lack of adequate knowledge and data on feasibility of remote outpatient monitoring.

In addition, the pre-TAVR monitoring will enhance our ability to predict and plan for interventions such as permanent pacemaker implantation. The primary objective of this project will be to facilitate the implementation of this monitoring technology into a busy tertiary care setting and better understand the conditions necessary for successful implementation. This will be achieved through ongoing stakeholder engagement (patient, provider, and hospital administrators) at all stages of the implementation program and close evaluation of quality metrics to ensure fidelity of the m-CARDS™ system.

Overall, implementation of this system is expected to impact the following levels of the health care system:

i) Patient-Level: Improved quality of life through "better care closer to home" facilitated by physician supported monitoring before TAVI and post-TAVI discharge from hospital.

ii) Provider-Level/Organizational-Level: Integrate the m-CARDS™ system into a busy TAVI clinical care pathway that can be adapted at other TAVI centres and ensure physician/administrator engagement/confidence in this novel technology.

iii) System-Level: Reduced (1) hospital length of stay and associated costs, (2) readmissions and unplanned medical visits, and (3) likelihood of hospital acquired infections.

Eligibility criteria: Inclusion Criteria:

* All patients selected for TAVI procedure that do not meet exclusion criteria and provide informed consent.

Exclusion Criteria:

* Patients with prior PPM or ICD
* Patient in-hospital awaiting TAVI
* Resting 12-lead ECG shows first degree AV block, plus LAHB plus RBBB; high grade 2nd or 3rd degree heart block

Primary outcomes:
measure: Feasibility: Recruitment rate
timeFrame: End of study (Approximately Month 24)
measure: Feasibility: Participant adherence to monitoring pre-TAVI
timeFrame: End of pre-TAVI monitoring period (Day 14)
measure: Feasibility: Participant adherence to monitoring post-TAVI
timeFrame: End of post-TAVI monitoring period (approximately Month 2 dependent on scheduling of TAVI procedure)
measure: Feasibility: Requirement for PPM pre-TAVI
timeFrame: End of pre-TAVI monitoring period (Day 14)
measure: Feasibility: Participant adherence to post-TAVI monitoring protocol
timeFrame: End of post-TAVI monitoring period (approximately Month 2)
measure: Feasibility: Timeliness of medical assessment of participants with "serious" arrhythmia identified on monitor pre-TAVI
timeFrame: End of pre-TAVI monitoring period (Day 14)
measure: Feasibility: Timeliness of medical assessment of participants with "serious" arrhythmia identified on monitor post-TAVI
timeFrame: End of post-TAVI monitoring period (approximately Month 2)
measure: Patient Experience Questionnaire
timeFrame: 30-day follow-up
measure: Clinical Team Experience Questionnaire
timeFrame: 30-day follow-up
measure: Number of participant or clinical team activations based on monitor findings pre-TAVI
timeFrame: End of pre-TAVI monitoring period (Day 14)
measure: Number of participant or clinical team activations based on monitor findings post-TAVI
timeFrame: End of post-TAVI monitoring period (approximately Month 2)
measure: Time from identification of findings on remote monitor to clinical team activation for pre-TAVI findings.
timeFrame: End of pre-TAVI monitoring period (Day 14)
measure: Time from identification of findings on remote monitor to clinical team activation for post-TAVI findings.
timeFrame: End of post-TAVI monitoring period (approximately Month 2)
Secondary outcomes:
measure: Hospital length of stay post-TAVI
timeFrame: Month 2 (approximate, dependent on scheduling of TAVI procedure)
measure: Arrhythmia-related unplanned re-hospitalization
timeFrame: 30-day post-TAVI follow-up assessment
measure: New onset of advanced AVB pre-TAVI
timeFrame: End of pre-TAVI monitoring period (Day 14)
measure: New onset of advanced AVB post-TAVI
timeFrame: End of post-TAVI monitoring period (approximately Month 2)
measure: New onset paroxysmal AF pre-TAVI
timeFrame: End of pre-TAVI monitoring period (Day 14)
measure: New onset paroxysmal AF post-TAVI
timeFrame: End of post-TAVI monitoring period (approximately Month 2)
measure: New onset atrial tachycardia pre-TAVI
timeFrame: End of pre-TAVI monitoring period (Day 14)
measure: New onset atrial tachycardia post-TAVI
timeFrame: End of post-TAVI monitoring period (approximately Month 2)
measure: New onset NSVT pre-TAVI
timeFrame: End of pre-TAVI monitoring period (Day 14)
measure: New onset NSVT post-TAVI
timeFrame: End of post-TAVI monitoring period (approximately Month 2)
measure: New sustained VT pre-TAVI
timeFrame: End of pre-TAVI monitoring period (Day 14)
measure: New sustained VT post-TAVI
timeFrame: End of post-TAVI monitoring period (approximately Month 2)
measure: Severe bradycardia pre-TAVI
timeFrame: End of pre-TAVI monitoring period (Day 14)
measure: Severe bradycardia post-TAVI
timeFrame: End of post-TAVI monitoring period (approximately Month 2)
measure: New onset persistent LBBB
timeFrame: Month 2 (approximate, dependent on scheduling of TAVI procedure)
measure: Temporary PM required post-TAVI
timeFrame: Month 2 (approximate, depending on scheduling of TAVI procedure)
measure: Total number of PPM implantations
timeFrame: 30-day post-TAVI follow-up
measure: Total hospitalization days up to 30 days post-TAVI
timeFrame: 30-day post-TAVI follow-up
measure: Emergency Department (ED) Visits
timeFrame: 30-day post-TAVI follow-up
measure: Health care utilization costs
timeFrame: 30-day post-TAVI follow-up
measure: Syncope requiring medical assessment
timeFrame: 30-day post-TAVI follow-up
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation - Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Madhu Natarajan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Natarajan MK, Sheth TN, Wijeysundera HC, Chavarria J, Rodes-Cabau J, Velianou JL, Radhakrishnan S, Newman T, Smith A, Wong JA, Schwalm JD, Duong M, Mian RI, Bishop MG, Healey JS. Remote ECG monitoring to reduce complications following transcatheter aortic valve implantations: the Redirect TAVI study. Europace. 2022 Oct 13;24(9):1475-1483. doi: 10.1093/europace/euac042.