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
Phase-Based Effectiveness
N/A
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
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
TAVR
1 of 1
Experimental Treatment
500 Total Participants · 1 Treatment Group
Primary Treatment: ECG monitoring for Conduction Disturbances · No Placebo Group · N/A
TAVR
Other
Experimental Group · 1 Intervention: ECG monitoring for Conduction Disturbances · Intervention Types: OtherTrial 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, 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." - Anonymous Online Contributor
Unverified Answer