ECG monitoring for Conduction Disturbances for Transcatheter Aortic Valve Replacement

Mackram F. Eleid, M.D., Rochester, MN
Transcatheter Aortic Valve ReplacementECG monitoring for Conduction Disturbances - Other
All Sexes

Study Summary

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

Treatment Effectiveness

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: 14 days

1 Day of Procedure
Evaluate Cara usability using a dedicated questioner
14 days
Evaluate Cara Safety, collecting Adverse Events
Evaluate Cara performance in reduction of New Onset Conduction Disturbances (NOCD)
Atrioventricular Block

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

500 Total Participants · 1 Treatment Group

Primary Treatment: ECG monitoring for Conduction Disturbances · No Placebo Group · N/A

Experimental Group · 1 Intervention: ECG monitoring for Conduction Disturbances · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 14 days

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

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to have a heart condition that is suitable for TAVR (Transcatheter Aortic Valve Replacement) using approved medical devices.

Frequently Asked Questions

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

"Contrary to initial expectations, 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.