Remote ECG Monitoring of TAVI Patients

Aortic Valve Stenosis Clinical Trial

Official title:

Remote ECG Monitoring to Reduce Complications Following Transcatheter Aortic Valve Implantations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03810820
• Other study ID #: REdireCT TAVI
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 20, 2018
• Est. completion date: July 30, 2021

Study information

• Verified date: February 2021
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Cardiac Valve Disease
• Heart Valve Diseases

Intervention

Device:
• mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS)
A wearable cardiac monitoring device is provided to patients pre- and post-TAVI. The monitor transmits cardiac data in real time to the m-CARDs team. Cardiac abnormalities are reported to the clinical team who then assess the abnormality and intervene as clinically necessary.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences Corporation - Hamilton General Hospital	Hamilton	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Population Health Research Institute	Hamilton Health Sciences Corporation, M-Health Solutions, Southlake Regional Health Centre, Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Recruitment rate	To achieve recruitment of at least 80% of eligible patients and to describe reasons for non-participation.	End of study (Approximately Month 24)
Primary	Feasibility: Participant adherence to monitoring pre-TAVI	To achieve patient level adherence to monitoring at least 80% of the expected time (total # of days (hours) of loop monitoring pre-TAVI).	End of pre-TAVI monitoring period (Day 14)
Primary	Feasibility: Participant adherence to monitoring post-TAVI	To achieve patient level adherence to monitoring at least 80% of the expected time (total # of days (hours) of loop monitoring post-TAVI).	End of post-TAVI monitoring period (approximately Month 2 dependent on scheduling of TAVI procedure)
Primary	Feasibility: Requirement for PPM pre-TAVI	Pre-TAVI identification of at least 5-10% of the cohort population who would need permanent pacemaker (either heart block or characteristics high risk for heart block).	End of pre-TAVI monitoring period (Day 14)
Primary	Feasibility: Participant adherence to post-TAVI monitoring protocol	To facilitate complete success with post-discharge monitoring in > 80% of recruited and eligible participants (wearing monitor on same day as discharge for at least one week).	End of post-TAVI monitoring period (approximately Month 2)
Primary	Feasibility: Timeliness of medical assessment of participants with "serious" arrhythmia identified on monitor pre-TAVI	To have 80% rate of medical assessment within 24 hours for any recruited and eligible patients with identified "serious" arrhythmia pre-TAVI.	End of pre-TAVI monitoring period (Day 14)
Primary	Feasibility: Timeliness of medical assessment of participants with "serious" arrhythmia identified on monitor post-TAVI	To have 80% rate of medical assessment within 24 hours for any recruited and eligible patients with identified "serious" arrhythmia post-TAVI.	End of post-TAVI monitoring period (approximately Month 2)
Primary	Patient Experience Questionnaire	Survey of patient experience related to shortened length of hospital stay due to remote ECG monitoring via loop monitor and experience of care given when there are clinical findings on loop monitor	30-day follow-up
Primary	Clinical Team Experience Questionnaire	Survey of clinical team experience related to implementation of a new clinical pathway for pre- and post-procedure care of TAVI patients.	30-day follow-up
Primary	Number of participant or clinical team activations based on monitor findings pre-TAVI	Total number of clinical team and participant activations, along with a) Inappropriate clinical team and participant activations - clinical team is activated but no patient intervention is undertaken and b) Inappropriate negative activations - arrhythmia event is seen on loop monitoring but clinical team is not activated.	End of pre-TAVI monitoring period (Day 14)
Primary	Number of participant or clinical team activations based on monitor findings post-TAVI	Total number of clinical team and participant activations, along with a) Inappropriate clinical team and participant activations - clinical team is activated but no patient intervention is undertaken and b) Inappropriate negative activations - arrhythmia event is seen on loop monitoring but clinical team is not activated.	End of post-TAVI monitoring period (approximately Month 2)
Primary	Time from identification of findings on remote monitor to clinical team activation for pre-TAVI findings.	Time from when a finding is noted on remote monitor to the time the clinical team is activated to assess and intervene with the participant.	End of pre-TAVI monitoring period (Day 14)
Primary	Time from identification of findings on remote monitor to clinical team activation for post-TAVI findings.	Time from when a finding is noted on remote monitor to the time the clinical team is activated to assess and intervene with the participant.	End of post-TAVI monitoring period (approximately Month 2)
Secondary	Hospital length of stay post-TAVI	Duration of hospitalization post-TAVI procedure.	Month 2 (approximate, dependent on scheduling of TAVI procedure)
Secondary	Arrhythmia-related unplanned re-hospitalization	Unscheduled hospitalization or prolongation of hospitalization for heart rhythm reasons or PPM insertion pre- or post-TAVI.	30-day post-TAVI follow-up assessment
Secondary	New onset of advanced AVB pre-TAVI	Defined as 2:1 second-degree or higher AVB.	End of pre-TAVI monitoring period (Day 14)
Secondary	New onset of advanced AVB post-TAVI	Defined as 2:1 second-degree or higher AVB.	End of post-TAVI monitoring period (approximately Month 2)
Secondary	New onset paroxysmal AF pre-TAVI	Defined as any irregular atrial rhythm with absence of consistent P waves lasting > 6 seconds.	End of pre-TAVI monitoring period (Day 14)
Secondary	New onset paroxysmal AF post-TAVI	Defined as any irregular atrial rhythm with absence of consistent P waves lasting > 6 seconds.	End of post-TAVI monitoring period (approximately Month 2)
Secondary	New onset atrial tachycardia pre-TAVI	Defined as period of sudden rapid and regular atrial rhythm with identifiable P waves.	End of pre-TAVI monitoring period (Day 14)
Secondary	New onset atrial tachycardia post-TAVI	Defined as period of sudden rapid and regular atrial rhythm with identifiable P waves.	End of post-TAVI monitoring period (approximately Month 2)
Secondary	New onset NSVT pre-TAVI	Defined as runs of >/= 3 ventricular beats at a heart rate of > 100 bpm lasting < 30 seconds.	End of pre-TAVI monitoring period (Day 14)
Secondary	New onset NSVT post-TAVI	Defined as runs of >/= 3 ventricular beats at a heart rate of > 100 bpm lasting < 30 seconds.	End of post-TAVI monitoring period (approximately Month 2)
Secondary	New sustained VT pre-TAVI	Defined as ventricular runs lasting >/= 30 seconds.	End of pre-TAVI monitoring period (Day 14)
Secondary	New sustained VT post-TAVI	Defined as ventricular runs lasting >/= 30 seconds.	End of post-TAVI monitoring period (approximately Month 2)
Secondary	Severe bradycardia pre-TAVI	Defined as heart rate < 40 bpm.	End of pre-TAVI monitoring period (Day 14)
Secondary	Severe bradycardia post-TAVI	Defined as heart rate < 40 bpm.	End of post-TAVI monitoring period (approximately Month 2)
Secondary	New onset persistent LBBB	Defined as new onset LBBB after TAVI that persisted at hospital discharge.	Month 2 (approximate, dependent on scheduling of TAVI procedure)
Secondary	Temporary PM required post-TAVI	Temporary PM not removed within 4 hours of completion of leaving procedure room.	Month 2 (approximate, depending on scheduling of TAVI procedure)
Secondary	Total number of PPM implantations	Total number of PPM implantations that are either planned (if the inciting heart rhythm was identified on monitor and implantation of PPM was arranged) or unplanned (if the monitor was not the initiating factor).	30-day post-TAVI follow-up
Secondary	Total hospitalization days up to 30 days post-TAVI	Number of days in hospital after discharge from TAVI procedure.	30-day post-TAVI follow-up
Secondary	Emergency Department (ED) Visits	Number of ED visits.	30-day post-TAVI follow-up
Secondary	Health care utilization costs	Costs associated with length of stay, ED use, re-admission to hospital and outpatient clinic visits will be calculated.	30-day post-TAVI follow-up
Secondary	Syncope requiring medical assessment	Any incident of syncope that requires medical assessment.	30-day post-TAVI follow-up