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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device called the Cara CDRM (Conduction Disturbance Risk Monitor) 2.0, which checks for heart rhythm issues after a TAVR procedure (a heart valve replacement). Researchers aim to determine if this device can better predict and reduce heart rhythm problems compared to usual care practices. Candidates for this trial include those already planning to undergo the TAVR procedure and willing to follow up for two weeks afterward. Initially, the trial will collect data from 50 participants to evaluate the monitor's accuracy, then compare it with standard practices in a second stage. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve heart care for future patients.

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 prior data suggests that the Cara Monitor is safe for use during TAVR procedures?

Research has shown that the Cara CDRM 2.0 device, used to monitor heart rhythm issues after a heart valve procedure called TAVR, is generally easy for patients to use. Similar studies have found that new heart rhythm problems, such as changes in heartbeat patterns, are common after TAVR. However, these problems usually do not lead to serious complications. For example, one study found that about 5% of patients experienced heart rhythm episodes, but no deaths were reported after one month.

The Cara CDRM 2.0 is a mobile heart monitor that checks heart rhythms without needing to be worn continuously, distinguishing it from other monitors. This method aims to detect any new heart rhythm changes early. No serious safety concerns have been identified while using this monitor. The current trial will provide more information on how well the device predicts and manages these heart rhythm changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cara CDRM 2.0 because it offers a new way to monitor heart rhythm disturbances after TAVR procedures. Unlike traditional ECG monitors, this device actively analyzes 12-lead ECGs to detect New-Onset Conduction Disturbances (NOCD) in real-time, potentially alerting doctors to issues earlier. This proactive approach could lead to quicker interventions and better patient outcomes, setting it apart from standard post-procedure monitoring methods.

What evidence suggests that the Cara Monitor is effective for detecting heart rhythm disturbances post-TAVR?

Research has shown that heart rhythm problems commonly occur after TAVR (Transcatheter Aortic Valve Replacement). In this trial, the Cara CDRM 2.0 device will detect changes in heart rhythm during the procedure. It offers real-time heart monitoring to identify small changes, potentially predicting and reducing new rhythm problems. Early results suggest that this monitoring can detect changes at each step of the TAVR process. This might reduce the need for permanent pacemakers, which are sometimes required after TAVR due to heart rhythm issues. ^{1 2 3 6 7}

Who Is on the Research Team?

Helena Grinberg, PhD

Principal Investigator

Cara Medical Ltd

Are You a Good Fit for This Trial?

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 eligible for a heart valve replacement using approved devices.

Provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05465655

Cara CDRM (Conduction Disturbance Risk Monitor) 2.0 Prospective, multicenter, roll-in, pilot clinical trial. Study subjects will be studied during the TAVR procedure and their 12 lead ECGs collected and analyzed ...

2. withpower.com withpower.com/trial/phase-transcatheter-aortic-valve-replacement-tavr-7-2022-5b677

ECG Monitoring for Post-TAVR Heart Rhythm Disturbances ... 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39341432/

Real-time analysis of conduction disturbances during ... The CARA system facilitated real-time ECG monitoring, detecting subtle and progressive changes during TAVR. ECG changes occurred at each step.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S193687982401029X

Conduction Disturbances After Transcatheter Aortic Valve ... Conduction disturbances are a frequent adverse event after TAVR, with only a few studies showing permanent pacemaker rates in the 1-digit frame.

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

Ambulatory Electrocardiogram Monitoring in Patients ... To date, studies using AECG monitoring detected symptomatic or asymptomatic bradyarrhythmias or tachyarrhythmias in ∼15% of patients before TAVR ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12209152/

Management of conduction disturbances after TAVI The incidence of new-onset cardiac conduction disturbances following transcatheter aortic valve implantation (TAVI) has not decreased compared to other ...

7. jacc.org jacc.org/doi/10.1016/j.jcin.2021.08.039

Ambulatory Electrocardiographic Monitoring Following ... Systematic 2-week AECG monitoring following minimalist TAVR detected HAVB and CHB episodes in about 5% of cases, with no mortality at 1 month.