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ECG Monitoring

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

N/A

Recruiting

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

Cara CDRM Trial Summary

This trial will enroll 50 people to study the effect of a Cara Monitor on reducing New-Onset Conduction Disturbances post TAVR.

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.Check my eligibility

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.See study design

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.

Cara CDRM Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate Cara Safety, collecting Adverse Events

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

Atrioventricular Block

+1 more

Cara CDRM 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Cara Medical LtdLead Sponsor

3 Previous Clinical Trials

800 Total Patients Enrolled

K2 Medical LtdLead Sponsor

3 Previous Clinical Trials

800 Total Patients Enrolled

Helena Grinberg, PhDStudy ChairCara Medical Ltd

1 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

Cara CDRM (Conduction Disturbance Risk Monitor) 2.0 (ECG Monitoring) Clinical Trial Eligibility Overview. Trial Name: NCT05465655 — N/A

Transcatheter Aortic Valve Replacement Research Study Groups: Patients undergoing TAVR

Transcatheter Aortic Valve Replacement Clinical Trial 2023: Cara CDRM (Conduction Disturbance Risk Monitor) 2.0 Highlights & Side Effects. Trial Name: NCT05465655 — N/A

Cara CDRM (Conduction Disturbance Risk Monitor) 2.0 (ECG Monitoring) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05465655 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an ongoing call for individuals to join this research endeavor?

"Contrary to initial expectations, clinicaltrials.gov records demonstrate that this medical trial has stopped recruiting patients since July 19th 2022. However, there are 12 other studies actively enrolling individuals at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cara CDRM (Conduction Disturbance Risk Monitor) 2.0

2022. "Cara CDRM (Conduction Disturbance Risk Monitor) 2.0". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05465655.