Continuous Electrocardiogram Monitoring for TAVR Patients

Not currently recruiting at 1 trial location

Overseen By Emilie Pelletier Beaumont, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Pacemaker, In-hospital death, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if continuous heart monitoring can identify irregular heartbeats in patients who have undergone a TAVI procedure for severe aortic stenosis (a heart valve problem). The researchers seek to discover whether using a device called Cardiostat (a continuous electrocardiogram monitoring device) can help doctors detect these heart rhythm issues early for immediate treatment. The trial seeks participants who have had a TAVI procedure with either balloon or self-expandable valves and do not have a pacemaker. As an unphased trial, it offers participants the chance to contribute to important research that could enhance heart monitoring techniques for future patients.

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

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

What prior data suggests that continuous ECG monitoring is safe for TAVR patients?

Research has shown that Cardiostat, a device for continuous heart monitoring, is safe for patients undergoing TAVI, a procedure to replace a heart valve. Although some problems can occur after TAVI, using a monitor like Cardiostat helps doctors detect issues early, allowing for quick intervention if necessary. This method avoids drug-related side effects by not using medication and focuses on closely monitoring heart rhythms. This approach is generally well-tolerated and can be crucial for early intervention. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about continuous electrocardiogram (ECG) monitoring for TAVR patients because it offers a real-time, detailed view of heart activity, which standard post-procedure monitoring may not provide. Unlike traditional methods that might rely on periodic checks, continuous ECG monitoring can detect irregular heart rhythms as they happen, potentially leading to quicker interventions and better outcomes. This approach could help improve patient safety and reduce complications by offering a more precise and comprehensive assessment of heart health after TAVR procedures.

What evidence suggests that ECG monitoring is effective for TAVR patients?

Research has shown that continuous ECG monitoring, such as Cardiostat, benefits patients after a TAVR procedure, a type of heart valve replacement. In this trial, all participants will receive ECG monitoring. Studies have found that this monitoring can detect irregular heartbeats soon after the procedure. For example, a study by Tian showed that it is safe and effective for spotting new heart rhythm issues after TAVR. Another study discovered that this monitoring can also reveal serious heart block problems both before and after TAVR. Overall, continuous ECG monitoring helps identify these issues early, allowing for quick treatment and better health outcomes for patients. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for patients with severe aortic stenosis who are about to undergo TAVI using balloon or self-expandable valves. It's not for those who may die in the hospital, can't be monitored by ECG after the procedure, already have a pacemaker, won't consent to the study, or are in another similar ECG monitoring trial.

Inclusion Criteria

I have severe aortic stenosis and am undergoing TAVI with a specific type of valve.

Exclusion Criteria

You have a pacemaker implanted before or after a medical procedure.

Failure to provide informed consent.

Not applicable as I am alive.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

TAVI Procedure

Participants undergo the Transcatheter Aortic Valve Implantation (TAVI) procedure

1 day

Post-Procedural Monitoring

Continuous ECG monitoring using the CardioSTAT® device after hospital discharge

4 weeks

2 visits (in-person) at 2 and 4 weeks

Follow-up

Participants are monitored for arrhythmic events and treatment modifications

5 years

Yearly visits up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Cardiostat

Trial Overview The RECORD Study is testing continuous ECG monitoring using Cardiostat on patients after they've had TAVI. The goal is to see if this monitoring helps catch and treat heart rhythm problems that happen right after the surgery.

How Is the Trial Designed?

Group I: ECG monitoring Experimental Treatment 1 Intervention

All patient will be under telemetry

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+

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Lead Sponsor

Trials

26

Recruited

6,300+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.119.008674

Role of Continuous ECG Monitoring to Improve ... Tian's study provides further evidence on the safety and effectiveness of ambulatory cardiac monitoring in new-onset LBBB post-TAVR patients, ...

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

Focus on Transcatheter Aortic Valve Replacement ... This study sought to determine, using continuous electrocardiographic monitoring (CEM) pre–transcatheter aortic valve replacement (TAVR), the incidence and ...

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

Ambulatory Electrocardiogram Monitoring in Patients ... This review provides an overview of the current status, clinical implications, and future perspectives of AECG monitoring in the TAVR setting.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7499381/

Remote Ambulatory Cardiac Monitoring Before and After ... Remote ambulatory cardiac monitoring (rACM) could identify high-grade atrioventricular block (AVB) before and after transcatheter aortic valve replacement (TAVR) ...

5. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(21)02353-5/fulltext

Bradyarrhythmias detected by extended rhythm recording ... Bradyarrhythmias are common and can be detected with extended ECG monitoring before and after TAVR; however, in our study they did not predict ...

6. jacc.org jacc.org/doi/10.1016/j.jacc.2025.03.004

5-Year Outcomes After Transcatheter or Surgical Aortic ... Including the vital status sweep data, the all-cause mortality rate at 5 years for patients undergoing TAVR was 14.7% and for surgery was 15.2% ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.071838?doi=10.1161/CIRCULATIONAHA.124.071838

Outcomes of Transcatheter Aortic Valve Replacement in ... One-year outcomes among real-world trial-eligible patients are excellent, but adverse events are higher compared with published clinical trial data.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0828282X24004070

Systematic Review/Meta-analysis Outcomes and Safety of ... Overall, our observational data suggest a potentially higher mortality rate among patients who underwent TCv-TAVR compared with transfemoral TAVR, likely ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25511236/

Long-term outcomes associated with the transaortic ... Results: TAO TAVR was associated with a trend towards lower all-cause mortality at 1 year compared to TAP TAVR (18% vs. 34%, P=0.09 in the overall sample; 12% ...

10. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2824469

Trends in Transcatheter Aortic Valve Replacement Outcomes Median (IQR) STS predicted risk of mortality (STS-PROM) was 3.3% (2.0%-5.3%). Median (IQR) baseline KCCQ-OS score was 50 (31-71), ...