Remote ECG Monitoring of TAVI Patients

NCT03810820 | Unknown DMC

• 1 other identifier: REdireCT TAVI
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Valve Disease; Aortic Valve Stenosis

Keywords

TAVR; TAVI; Heart block; Atrial fibrillation; Cardiac arrhythmias; Permanent pacemaker; Remote cardiac monitoring; Loop monitor

Outcome Measures

Primary Outcomes (13)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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

• 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

• 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)

• 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)

• 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)

• 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 Outcomes (21)

• Hospital length of stay post-TAVI

  Month 2 (approximate, dependent on scheduling of TAVI procedure)

• Arrhythmia-related unplanned re-hospitalization

  30-day post-TAVI follow-up assessment

• New onset of advanced AVB pre-TAVI

  End of pre-TAVI monitoring period (Day 14)

• New onset of advanced AVB post-TAVI

  End of post-TAVI monitoring period (approximately Month 2)

• New onset paroxysmal AF pre-TAVI

  End of pre-TAVI monitoring period (Day 14)

Study Arms (1)

Outpatient TAVI

OTHER

Consecutive patients scheduled for outpatient TAVI.

Device: mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS)

Interventions

mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS) DEVICE

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.

Outpatient TAVI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Health Research Institute: lead
• Hamilton Health Sciences Corporation: collaborator
• Southlake Regional Health Centre: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• M-Health Solutions: collaborator

Study Sites (1)

Hamilton Health Sciences Corporation - Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

• 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.

  PMID: 35699482 DERIVED

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Stenosis; Heart Block; Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Madhu Natarajan, M.D.

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort of consecutive patients booked for outpatient TAVI.

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: January 22, 2019
• Study Start: June 20, 2018
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)