What side effects are associated with this type of intervention?

Common treatments for Transcatheter Aortic Valve Replacement (TAVR) include the use of various types of transcatheter heart valves. Known side effects of TAVR procedures can include vascular complications, bleeding, stroke, and new-onset conduction disturbances such as atrioventricular block, which may necessitate the implantation of a permanent pacemaker. The Cara Monitor trial specifically studies the prediction and reduction of these conduction disturbances, highlighting their significance as a common post-TAVR complication.

What prior FDA approvals exist?

Transcatheter Aortic Valve Replacement (TAVR) has seen several FDA approvals for devices designed to treat aortic stenosis in patients who are at high or prohibitive risk for open-heart surgery. Notable FDA-approved TAVR devices include the Edwards SAPIEN valve series and the Medtronic CoreValve series. These devices have been pivotal in providing less invasive options for valve replacement. While the Cara Monitor trial focuses on predicting and reducing new-onset conduction disturbances post-TAVR, specific FDA-approved treatments or devices for this particular complication are not detailed in the provided context.

What other types of research exist?

Promising alternatives to the Cara Monitor for TAVR patients include: 1) Advanced implantable loop recorders (ILRs) that provide continuous cardiac monitoring and early detection of arrhythmias. 2) Wearable cardiac monitors with real-time data transmission and AI-driven analytics for early intervention. 3) Enhanced electrophysiological mapping systems used intraoperatively to predict and mitigate conduction disturbances. 4) Integration of machine learning algorithms with existing cardiac monitoring devices to improve predictive accuracy and patient outcomes.

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ECG Monitoring

ECG Monitoring for Post-TAVR Heart Rhythm Disturbances (Cara CDRM Trial)

N/A

Waitlist Available

Research Sponsored by Cara Medical Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the Cara Monitor, a device that tracks heart activity, on patients undergoing TAVR. It aims to see if the monitor can predict and reduce new heart rhythm problems by continuously recording and analyzing the heart's electrical activity.

Who is the study for?

This trial is for adults over 18 who need a heart valve replacement (TAVR) and can give informed consent. They must be willing to follow the study's check-ups. People with implanted rhythm devices or those needing such devices, contraindications to TAVR, under legal age of consent, or in other trials can't join.

What is being tested?

The Cara CDRM Monitor's ability to predict new heart rhythm issues after TAVR is being tested. Initially, 50 patients will have their ECGs monitored before, during, and up to two weeks after TAVR. The second phase will compare the monitor's effectiveness against standard practices at each site.

What are the potential side effects?

Since this trial involves monitoring with an ECG rather than testing a drug or invasive procedure, there are no direct side effects from the intervention itself; however routine risks associated with undergoing TAVR and ECG procedures apply.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate Cara Safety, collecting Adverse Events

Evaluate Cara performance in reduction of New Onset Conduction Disturbances (NOCD)

Atrioventricular Block

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients undergoing TAVRExperimental Treatment1 Intervention

Study subjects will be studied during the TAVR procedure and their 12 lead ECGs collected and analyzed notifying for New-Onset Conduction Disturbances (NOCD) using Cara Monitor.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Transcatheter Aortic Valve Replacement (TAVR) patients include beta-blockers, antiarrhythmic drugs, and catheter ablation. Beta-blockers reduce heart rate and myocardial oxygen demand, helping to manage arrhythmias. Antiarrhythmic drugs stabilize cardiac electrical activity to prevent or correct arrhythmias. Catheter ablation targets and destroys small areas of heart tissue causing abnormal electrical signals. These treatments are essential for TAVR patients as they help manage and prevent conduction disturbances, a common complication post-TAVR, thereby improving patient outcomes.