Stopped: Slow recruitment rate
Prospective, multicenter, roll-in, pilot clinical trial. Study subjects will be studied during the TAVR procedure and their 12 lead ECGs collected and analyzed for New-Onset Conduction Disturbances (NOCD). The study will be conducted in two stages: During the first roll-in stage of the study, 50 intended to undergo TAVR (all comers) will be enrolled. Data will be collected according to the study schedule below of pre-, during and after the TAVR procedure up to 14 days FU. This data for the first 50 patients will be analyzed to evaluate the ability of the Cara Monitor prediction of NOCD post TAVR. The second stage of the stage will be conducted upon completion of the first stage analysis and will be considered to randomize 1:1 the subjects connected to Cara Monitor during the procedure versus site-specific current practice. The effect of Cara Monitor on reduction of NOCD post TAVR compared to patients treated and followed per regular site-specific practice will be estimated.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Evaluate Cara performance in reduction of New Onset Conduction Disturbances (NOCD)
Timeframe: 14 days
Evaluate Cara performance in reduction of Permanent Pacemaker (PPM) or High-Grade AV Block (HGAVB)
Timeframe: 14 days
Evaluate Cara usability using a dedicated questioner
Timeframe: 1 Day of Procedure
Evaluate Cara Safety, collecting Adverse Events
Timeframe: 14 days