Cardiac Valve DiseaseNCT03810820
Remote ECG Monitoring of TAVI Patients
A study testing mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS) in people with Cardiac Valve Disease and Aortic Valve Stenosis, run by Population Health Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Valve Disease, Aortic Valve Stenosis
- What is being tested?
- mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jun 2018to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients selected for TAVI procedure that do not meet exclusion criteria and provide informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences Corporation - Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
About this study
Official title: Remote ECG Monitoring to Reduce Complications Following Transcatheter Aortic Valve Implantations
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.
Read the 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:
- 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.
- Conditions
- Cardiac Valve Disease, Aortic Valve Stenosis
- Being tested
- mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS)
- Keywords
- TAVR, TAVI, Heart block, Atrial fibrillation, Cardiac arrhythmias, Permanent pacemaker, Remote cardiac monitoring, Loop monitor
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Stenosis, Heart Block, Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient TAVI | Other | Consecutive patients scheduled for outpatient TAVI. Receives: Device: mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment rate
To achieve recruitment of at least 80% of eligible patients and to describe reasons for non-participation.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of post-TAVI monitoring period (approximately Month 2)
Secondary outcomes (21)
Hospital length of stay post-TAVI
Duration of hospitalization post-TAVI procedure.
Measured: Month 2 (approximate, dependent on scheduling of TAVI procedure)
Arrhythmia-related unplanned re-hospitalization
Unscheduled hospitalization or prolongation of hospitalization for heart rhythm reasons or PPM insertion pre- or post-TAVI.
Measured: 30-day post-TAVI follow-up assessment
New onset of advanced AVB pre-TAVI
Defined as 2:1 second-degree or higher AVB.
Measured: End of pre-TAVI monitoring period (Day 14)
New onset of advanced AVB post-TAVI
Defined as 2:1 second-degree or higher AVB.
Measured: End of post-TAVI monitoring period (approximately Month 2)
New onset paroxysmal AF pre-TAVI
Defined as any irregular atrial rhythm with absence of consistent P waves lasting > 6 seconds.
Measured: End of pre-TAVI monitoring period (Day 14)
New onset paroxysmal AF post-TAVI
Defined as any irregular atrial rhythm with absence of consistent P waves lasting > 6 seconds.
Measured: End of post-TAVI monitoring period (approximately Month 2)
New onset atrial tachycardia pre-TAVI
Defined as period of sudden rapid and regular atrial rhythm with identifiable P waves.
Measured: End of pre-TAVI monitoring period (Day 14)
New onset atrial tachycardia post-TAVI
Defined as period of sudden rapid and regular atrial rhythm with identifiable P waves.
Measured: End of post-TAVI monitoring period (approximately Month 2)
New onset NSVT pre-TAVI
Defined as runs of >/= 3 ventricular beats at a heart rate of > 100 bpm lasting < 30 seconds.
Measured: End of pre-TAVI monitoring period (Day 14)
New onset NSVT post-TAVI
Defined as runs of >/= 3 ventricular beats at a heart rate of > 100 bpm lasting < 30 seconds.
Measured: End of post-TAVI monitoring period (approximately Month 2)
New sustained VT pre-TAVI
Defined as ventricular runs lasting >/= 30 seconds.
Measured: End of pre-TAVI monitoring period (Day 14)
New sustained VT post-TAVI
Defined as ventricular runs lasting >/= 30 seconds.
Measured: End of post-TAVI monitoring period (approximately Month 2)
Severe bradycardia pre-TAVI
Defined as heart rate < 40 bpm.
Measured: End of pre-TAVI monitoring period (Day 14)
Severe bradycardia post-TAVI
Defined as heart rate < 40 bpm.
Measured: End of post-TAVI monitoring period (approximately Month 2)
New onset persistent LBBB
Defined as new onset LBBB after TAVI that persisted at hospital discharge.
Measured: Month 2 (approximate, dependent on scheduling of TAVI procedure)
Temporary PM required post-TAVI
Temporary PM not removed within 4 hours of completion of leaving procedure room.
Measured: Month 2 (approximate, depending on scheduling of TAVI procedure)
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).
Measured: 30-day post-TAVI follow-up
Total hospitalization days up to 30 days post-TAVI
Number of days in hospital after discharge from TAVI procedure.
Measured: 30-day post-TAVI follow-up
Emergency Department (ED) Visits
Number of ED visits.
Measured: 30-day post-TAVI follow-up
Health care utilization costs
Costs associated with length of stay, ED use, re-admission to hospital and outpatient clinic visits will be calculated.
Measured: 30-day post-TAVI follow-up
Syncope requiring medical assessment
Any incident of syncope that requires medical assessment.
Measured: 30-day post-TAVI follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start20 Jun 2018
- Primary completion30 Jul 2020
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort of consecutive patients booked for outpatient TAVI.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Southlake Health, Sunnybrook Health Sciences Centre, M-Health Solutions
- Responsible party
- Sponsor
- Investigators
- Madhu Natarajan, M.D., Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810820
- Sponsor's protocol ID
- REdireCT TAVI
- Status last verified
- Feb 2021
- First submitted
- 2 Nov 2018
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35699482
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote ECG Monitoring to Reduce Complications Following Transcatheter Aortic Valve Implantations
- ClinicalTrials.gov ID
- NCT03810820
- Acronym / sponsor ID
- REdireCT TAVI
- Conditions
- Cardiac Valve Disease, Aortic Valve Stenosis
- Keywords
- TAVR, TAVI, Heart block, Atrial fibrillation, Cardiac arrhythmias, Permanent pacemaker, Remote cardiac monitoring, Loop monitor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Southlake Health, Sunnybrook Health Sciences Centre, M-Health Solutions
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort of consecutive patients booked for outpatient TAVI.
| Arm | Type | Receives |
|---|---|---|
| Outpatient TAVI | Other | Device: mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS)Consecutive patients scheduled for outpatient TAVI. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients selected for TAVI procedure that do not meet exclusion criteria and provide informed consent.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Outpatient TAVI |
Primary outcome
Feasibility: Recruitment rate
Time frame: End of study (Approximately Month 24)
To achieve recruitment of at least 80% of eligible patients and to describe reasons for non-participation.
Feasibility: Participant adherence to monitoring pre-TAVI
Time frame: End of pre-TAVI monitoring period (Day 14)
To achieve patient level adherence to monitoring at least 80% of the expected time (total # of days (hours) of loop monitoring pre-TAVI).
Feasibility: Participant adherence to monitoring post-TAVI
Time frame: End of post-TAVI monitoring period (approximately Month 2 dependent on scheduling of TAVI procedure)
To achieve patient level adherence to monitoring at least 80% of the expected time (total # of days (hours) of loop monitoring post-TAVI).
Feasibility: Requirement for PPM pre-TAVI
Time frame: End of pre-TAVI monitoring period (Day 14)
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).
Feasibility: Participant adherence to post-TAVI monitoring protocol
Time frame: End of post-TAVI monitoring period (approximately Month 2)
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).
Feasibility: Timeliness of medical assessment of participants with "serious" arrhythmia identified on monitor pre-TAVI
Time frame: End of pre-TAVI monitoring period (Day 14)
To have 80% rate of medical assessment within 24 hours for any recruited and eligible patients with identified "serious" arrhythmia pre-TAVI.
Feasibility: Timeliness of medical assessment of participants with "serious" arrhythmia identified on monitor post-TAVI
Time frame: End of post-TAVI monitoring period (approximately Month 2)
To have 80% rate of medical assessment within 24 hours for any recruited and eligible patients with identified "serious" arrhythmia post-TAVI.
Patient Experience Questionnaire
Time frame: 30-day follow-up
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
Clinical Team Experience Questionnaire
Time frame: 30-day follow-up
Survey of clinical team experience related to implementation of a new clinical pathway for pre- and post-procedure care of TAVI patients.
Number of participant or clinical team activations based on monitor findings pre-TAVI
Time frame: End of pre-TAVI monitoring period (Day 14)
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.
Number of participant or clinical team activations based on monitor findings post-TAVI
Time frame: End of post-TAVI monitoring period (approximately Month 2)
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.
Time from identification of findings on remote monitor to clinical team activation for pre-TAVI findings.
Time frame: End of pre-TAVI monitoring period (Day 14)
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.
Time from identification of findings on remote monitor to clinical team activation for post-TAVI findings.
Time frame: End of post-TAVI monitoring period (approximately Month 2)
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.
21 secondary outcomes
Hospital length of stay post-TAVI
Time frame: Month 2 (approximate, dependent on scheduling of TAVI procedure)
Arrhythmia-related unplanned re-hospitalization
Time frame: 30-day post-TAVI follow-up assessment
New onset of advanced AVB pre-TAVI
Time frame: End of pre-TAVI monitoring period (Day 14)
New onset of advanced AVB post-TAVI
Time frame: End of post-TAVI monitoring period (approximately Month 2)
New onset paroxysmal AF pre-TAVI
Time frame: End of pre-TAVI monitoring period (Day 14)
New onset paroxysmal AF post-TAVI
Time frame: End of post-TAVI monitoring period (approximately Month 2)
New onset atrial tachycardia pre-TAVI
Time frame: End of pre-TAVI monitoring period (Day 14)
New onset atrial tachycardia post-TAVI
Time frame: End of post-TAVI monitoring period (approximately Month 2)
New onset NSVT pre-TAVI
Time frame: End of pre-TAVI monitoring period (Day 14)
New onset NSVT post-TAVI
Time frame: End of post-TAVI monitoring period (approximately Month 2)
New sustained VT pre-TAVI
Time frame: End of pre-TAVI monitoring period (Day 14)
New sustained VT post-TAVI
Time frame: End of post-TAVI monitoring period (approximately Month 2)
Severe bradycardia pre-TAVI
Time frame: End of pre-TAVI monitoring period (Day 14)
Severe bradycardia post-TAVI
Time frame: End of post-TAVI monitoring period (approximately Month 2)
New onset persistent LBBB
Time frame: Month 2 (approximate, dependent on scheduling of TAVI procedure)
Temporary PM required post-TAVI
Time frame: Month 2 (approximate, depending on scheduling of TAVI procedure)
Total number of PPM implantations
Time frame: 30-day post-TAVI follow-up
Total hospitalization days up to 30 days post-TAVI
Time frame: 30-day post-TAVI follow-up
Emergency Department (ED) Visits
Time frame: 30-day post-TAVI follow-up
Health care utilization costs
Time frame: 30-day post-TAVI follow-up
Syncope requiring medical assessment
Time frame: 30-day post-TAVI follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 35699482Natarajan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhu Natarajan, M.D. principal investigator
Population Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS) in people with Cardiac Valve Disease and Aortic Valve Stenosis, run by Population Health Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Recruitment rate (time frame: End of study (Approximately Month 24)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03810820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.