ECG Monitoring for Post-TAVR Heart Rhythm Disturbances

(Cara CDRM Trial)

Overseen By Helena Grinberg, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cara Medical Ltd

Disqualifiers: Implanted device, TAVR contraindication, others

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

Compensation: Varies

Number of Visits: 3

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cara CDRM 2.0 for monitoring heart rhythm disturbances after TAVR?

The research highlights the usefulness and potential clinical implications of ambulatory electrocardiogram (AECG) monitoring systems in patients undergoing TAVR, showing that these systems are safe and helpful in identifying arrhythmic disorders. This suggests that similar monitoring treatments, like Cara CDRM 2.0, could be effective in managing heart rhythm disturbances after TAVR. ^{1 2 3 4 5}

Is ECG monitoring safe for humans after TAVR?

Preliminary results from initial experiences using ambulatory ECG monitoring systems show that they are safe and useful for patients who have undergone TAVR. ^{1 3 6 7 8}

How is the treatment Cara CDRM 2.0 different from other treatments for post-TAVR heart rhythm disturbances?

Cara CDRM 2.0 is unique because it uses a non-continuous mobile ECG monitoring system to detect heart rhythm disturbances after TAVR, which is different from traditional continuous monitoring methods. This approach allows for spot checks using a digital mobile ECG device, potentially offering a more convenient and less invasive way to monitor patients. ^{1 2 4 5 9}

Research Team

Helena Grinberg, PhD

Principal Investigator

Cara Medical Ltd

Eligibility Criteria

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.

Inclusion Criteria

Willing to comply with specified follow-up evaluations

I am 18 years old or older.

I am eligible for a heart valve replacement using approved devices.

Exclusion Criteria

Any contraindication to the TAVR procedure according to the instructions for use

Planned treatment with any other investigational device, drug, or procedure (excluding registries) during the study period

Any implanted device or an indication for treatment with rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) at baseline

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedure

Collection of demographics, medical history, cardiac history, medications, and cardiac CT raw data

1 day

1 visit (in-person)

Procedure

12 lead ECG recorded and processed during TAVR procedure using Cara Monitor

1 day

1 visit (in-person)

Post-procedure (in hospital)

Patients connected to a 14-day ambulatory Holter monitor and standard 12 lead ECG recorded

14 days

Post-procedure (out of hospital)

Patients remain connected to ambulatory Holter monitor for 14 days post-procedure

14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

1 visit (in-person) at 30 days, 2 phone calls at 6 and 12 months

Treatment Details

Interventions

• Cara CDRM (Conduction Disturbance Risk Monitor) 2.0

Trial Overview 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.

Participant Groups

Group I: Patients undergoing TAVR Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Cara Medical Ltd

Lead Sponsor

Trials

4

Recruited

1,200+

K2 Medical Ltd

Lead Sponsor

Trials

4

Recruited

1,200+

References

1. England pubmed.ncbi.nlm.nih.gov

Non-continuous mobile electrocardiogram monitoring for post-transcatheter aortic valve replacement delayed conduction disorders put to the test. [2023]

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

Management of Conduction Disturbances Associated With Transcatheter Aortic Valve Replacement: JACC Scientific Expert Panel. [2020]

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

Ambulatory Electrocardiogram Monitoring in Patients Undergoing Transcatheter Aortic Valve Replacement: JACC State-of-the-Art Review. [2021]

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

Electrophysiologic Implications of Transcatheter Aortic Valve Replacement: Incidence, Outcomes, and Current Management Strategies. [2021]

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

Perioperative conduction disturbances after transcatheter aortic valve replacement. [2013]

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

Preprocedural and procedural variables that predict new-onset conduction disturbances after transcatheter aortic valve replacement. [2022]

7. Poland pubmed.ncbi.nlm.nih.gov

Usefulness of membranous septum length in the prediction of major conduction disturbances in patients undergoing transcatheter aortic valve replacement with different devices. [2021]

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

Myocardial Injury After Transcatheter Aortic Valve Replacement According to VARC-3 Criteria. [2023]

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

Electrocardiographic and electrophysiological predictors of atrioventricular block after transcatheter aortic valve replacement. [2020]