Continuous Electrocardiogram Monitoring for TAVR Patients
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.12345
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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
TAVI Procedure
Participants undergo the Transcatheter Aortic Valve Implantation (TAVI) procedure
Post-Procedural Monitoring
Continuous ECG monitoring using the CardioSTAT® device after hospital discharge
Follow-up
Participants are monitored for arrhythmic events and treatment modifications
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?
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Treatment groups
Experimental Treatment
All patient will be under telemetry
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Lead Sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Lead Sponsor
Citations
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, ...
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 ...
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.
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) ...
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 ...
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% ...
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ahajournals.org
ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.071838?doi=10.1161/CIRCULATIONAHA.124.071838Outcomes 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.
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 ...
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% ...
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), ...
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