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Remote ECG Monitoring of TAVI Patients

NCT03810820 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2021-02-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    collaborator OTHER

  • Southlake Regional Health Centre

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • M-Health Solutions

    collaborator UNKNOWN

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Madhu Natarajan, M.D. · Population Health Research Institute

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-20
Primary Completion
2020-07-30
Completion
2021-07-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03810820 on ClinicalTrials.gov