ECG Monitoring for Aortic Stenosis

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Disqualifiers: Urgent TAVI, Prior pacemaker

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to detect hidden heart rhythm issues in people with severe aortic stenosis (a condition where the heart valve narrows) before they undergo a TAVI procedure (a type of heart valve replacement). Continuous ECG monitoring (a test that records heart activity) for a week seeks to identify these silent problems early, allowing doctors to treat them and improve recovery afterward. This trial is suitable for patients approved for a TAVI procedure who do not already have a permanent pacemaker. As an unphased trial, it offers patients the opportunity to contribute to research that could enhance treatment outcomes for future TAVI patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that ECG monitoring is safe for patients with aortic stenosis?

Research shows that using an ECG (electrocardiogram) to check heart rhythms is safe. Studies have found that ECGs can detect both obvious and hidden heart rhythm issues in people with aortic stenosis. One study found that about 15% of patients had these issues before undergoing a TAVI procedure.

ECG monitoring involves wearing a small device that tracks heart rhythms over time, helping doctors identify any irregular heartbeats. This monitoring is safe and comfortable for patients, providing a non-invasive way to gather important information about heart health, which can aid doctors in making better treatment decisions.

Overall, ECG monitoring is easy to tolerate and poses minimal risk. It serves as a helpful tool for detecting heart rhythm problems early, potentially leading to better outcomes for patients with severe heart valve issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for aortic stenosis, which often focus on medication or surgical procedures like valve replacement, prolonged continuous ECG monitoring offers a non-invasive way to closely observe heart activity. Researchers are excited about using the CardioSTAT® device because it allows for detailed, continuous heart monitoring over a week, helping doctors catch irregularities that might be missed in shorter check-ups. This approach could lead to more accurate assessments and better-timed interventions, potentially improving outcomes for patients awaiting procedures like TAVI.

What evidence suggests that ECG monitoring is effective for detecting arrhythmias in aortic stenosis patients?

Research has shown that ECG monitoring, which participants in this trial will undergo, can help detect hidden heart rhythm problems in people with severe aortic stenosis. One study found that extended ECG monitoring successfully identified irregular heartbeats, known as arrhythmias. Detecting these arrhythmias before a TAVI procedure can help doctors provide better treatment, potentially improving recovery and shortening hospital stays. Other research suggests this method effectively diagnoses specific heart issues, such as atrial fibrillation and certain types of heart signal delays. Overall, ECG monitoring appears promising for early problem detection and improved care for people with aortic stenosis. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with severe aortic stenosis who are scheduled for a TAVI (Transcatheter Aortic Valve Implantation) procedure. Candidates must not require an urgent TAVI and should be able to undergo ECG monitoring for at least one week within three months before the procedure. Those with prior permanent pacemakers are excluded.

Inclusion Criteria

I have been approved for a TAVI procedure due to severe aortic stenosis.

Exclusion Criteria

I cannot have an ECG monitoring for a week due to urgent TAVI or other reasons.

Prior permanent pacemaker.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedural Monitoring

Participants undergo prolonged continuous ECG monitoring using the CardioSTAT® device

1 week

Continuous monitoring

TAVI Procedure and Hospitalization

Participants undergo the TAVI procedure and are monitored via telemetry until hospital discharge

Variable (until discharge)

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after the TAVI procedure

5 years

Clinical follow-up at 30 days, 1 year, and yearly thereafter

What Are the Treatments Tested in This Trial?

Interventions

• ECG monitoring

Trial Overview The study is testing whether prolonged continuous ECG monitoring before a TAVI procedure can detect silent arrhythmic events, which could lead to better pre-procedural treatment plans, improved patient outcomes, and reduced hospital stays after the surgery.

How Is the Trial Designed?

Group I: Prolonged continuous ECG monitoring Experimental Treatment 1 Intervention

Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure. The duration of the ECG monitoring will be of 1 week.

Who Is Running the Clinical Trial?

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Lead Sponsor

Trials

37

Recruited

9,700+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.036657

Clinical Outcomes According to Aortic Stenosis Management The 5‐year cumulative risk of death or AVR was 45.2% (95% CI, 42.3–48.1) in patients with mild AS, 75.3% (95% CI, 72.6–77.8) in patients with ...

2. academic.oup.com academic.oup.com/ehjdh/article/6/4/656/8180648

External assessment of an artificial intelligence-enabled ... The output of aortic stenosis positive labelled by artificial intelligence electrocardiogram (AI-ECG) compared with transthoracic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11168151/

Pilot study to evaluate the use of remote patient monitoring ... The aim of this pilot trial is to test the feasibility of a full-scale randomised controlled trial (RCT) to determine the utility of proactive surveillance in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11270444/

Ambulatory Smartwatch ECG Monitoring among Patients ... Our results suggested that the consumer smartwatch ECG demonstrated acceptable efficacy in diagnosing AF, LBBB, and RBBB. However, the sensitivity of smartwatch ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1936879820308165

Focus on Transcatheter Aortic Valve Replacement ... This was a prospective study including 106 patients with severe aortic stenosis and no prior permanent pacemaker screened for TAVR. A prolonged ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9457179/

Exercise Testing in Aortic Stenosis: Safety, Tolerability ... Results and conclusions: In patients with significant AS, exercise testing is safe, feasible and reveals symptoms in a significant proportion of ...

7. ahajournals.org ahajournals.org/doi/full/10.1161/JAHA.124.036599

Prognostic Value and Safety of Serial Exercise ... Our findings demonstrate the safety and prognostic utility of serial EECs in the management of patients with asymptomatic severe aortic stenosis to guide ...

8. jacc.org jacc.org/doi/10.1016/j.jacc.2020.12.062

Ambulatory Electrocardiogram Monitoring in Patients ... To date, studies using AECG monitoring detected symptomatic or asymptomatic bradyarrhythmias or tachyarrhythmias in ∼15% of patients before TAVR ...