4 Clinical Trials for Various Conditions
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.
The purpose of this study is to evaluate electrocardiogram (ECG) changes in 100 patients undergoing transcatheter aortic valve replacement (TAVR) to assess new-onset conduction abnormalities, such as atrioventricular nodal block (AVB) (1st, 2nd, or 3rd degree), or new-onset left bundle branch block (LBBB) that may occur during the procedure. Eligible patients enrolled in this study will be monitored with an FDA-approved ECG Holter system during TAVR, to assess intra-procedural changes. This will be a small-scale, early feasibility study performed to inform a future, larger-scale prospective investigation.
The purpose of the Optimize RV Follow-Up study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed. The goal of selective site pacing is to improve how the heart contracts when paced.
The purpose of the Optimize RV study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed. The goal of select site pacing is to improve how the heart contracts when paced in the ventricle. By pacing in select sites, it is possible to better copy the natural pattern of contraction of the heart.