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

106 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Patients with severe aortic stenosis candidates for a TAVI procedure harbor a high burden of silent arrhythmic events. Pre-procedural detection of such arrhythmias should help the investigators to implement specific therapeutic measures that may improve patient outcomes and reduce hospitalization length post-TAVI.

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.

How does ECG monitoring differ from other treatments for aortic stenosis?

ECG monitoring for aortic stenosis is unique because it uses a deep learning-based algorithm to detect the condition early by analyzing ECG data, which is different from traditional methods like echocardiography that focus on imaging the heart. This approach allows for non-invasive, early detection of significant aortic stenosis, potentially improving patient outcomes by identifying the condition before symptoms appear. ^{1 2 3 4 5}

What data supports the effectiveness of ECG monitoring as a treatment for aortic stenosis?

The research suggests that monitoring certain markers can help identify patients with aortic stenosis who are at high risk of heart problems, which may guide decisions about early treatment. While ECG monitoring specifically isn't mentioned, it could be useful in tracking these markers and managing the condition. ^{6 7 8 9 10}

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. England pubmed.ncbi.nlm.nih.gov

Risk stratification in asymptomatic severe aortic stenosis: a critical appraisal. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Atrial fibrillation is not an independent predictor of outcome in patients with aortic stenosis. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Spontaneous course of aortic valve disease. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical course of patients diagnosed with severe aortic stenosis in the Rotterdam area: insights from the AVARIJN study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Aortic stenosis: diagnosis and treatment. [2008]

6. England pubmed.ncbi.nlm.nih.gov

Deep Learning-Based Algorithm for Detecting Aortic Stenosis Using Electrocardiography. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Practical echocardiography in aortic valve stenosis. [2016]

8. Germany pubmed.ncbi.nlm.nih.gov

[Sudden cardiac death during long-term ECG monitoring of a patient with aortic stenosis]. [2006]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Echocardiographic Evaluation of Aortic Stenosis: A Comprehensive Review. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Multi-modality imaging in aortic stenosis: an EACVI clinical consensus document. [2023]