NCT05657912

Cara CDRS (Conduction Disturbance Risk Score) 1.0

A Continuous ECG Monitoring Data Collection Study in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR) to Evaluate the Performance of the Cara Monitor Conduction Disturbance Risk Score (CDRS).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 355 (actual)
• Sponsor: Cara Medical Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, non-randomized, multicenter data collection study. Eligible TAVR patients will be enrolled in the study. Cardiac conduction disturbances (CD) requiring permanent pacemaker implantation (PPM) or causing new-onset CD are frequent complications of TAVR that have been shown to be associated with increased mortality and re-hospitalization rates. The purpose of the study is to collect continuous ECG data in order to validate the performance of the Cara Conduction Disturbance Risk Score (CDRS) in patients undergoing transcatheter aortic valve replacement (TAVR). Subjects will be studied during the TAVR procedure and their ECG recordings according to the study schedule below of pre-, during, and after the TAVR procedure up to 14/30 days FU will be collected. 600 patients will be enrolled in this study with the hypothesis that Cara can deliver a statistically significant conduction disturbance risk stratification for patients undergoing TAVR. No investigation intervention is planned during this study. The Cara System analysis will be performed offline.

Detailed description

TAVR will be performed using site investigators' best practices including the use of standard-of-care catheters, devices, imaging, and monitoring modalities. Data will be collected to include the following patients' measures during this study: 1. Pre-procedure 1. Demographics 2. Medical history 3. Cardiac CT 4. 12 lead ECG 2. Procedure 1. Continuous 3-12 lead Holter will be supplied, data will be collected and analyzed by the study sponsor 2. Fluoroscopy (captured automatically by video system ) 3. Device manufacturer (type) and size 3. Post-procedure (in hospital) a. Continuous 1-3 lead Holter for 14 days will be supplied, and the data from the Holter recordings will be collected from the patient's home and analyzed. 4. Post-procedure (discharge) a. 12 lead ECG 5. Patients will be followed according to the current medical practice. Data to be collected during the FU : a. 12 lead ECG at 14/30 days The data collected from the study will be used to evaluate the performance Cara System, a conduction disturbance monitor that provides an indication of conduction disturbances during TAVR procedures. Conduction Disturbances (CD) outcome will be subdivided into: 1. PPM or High-Grade AV Block (HGAVB) 2. All other new onsets (or deterioration) of CD that are not listed in #1 3. No new onset CD

Conditions

• Transcatheter Aortic Valve Replacement

Interventions

Type	Name	Description
DEVICE	ECG monitoring	Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure

Timeline

• Start date: 2022-12-12
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2022-12-20
• Last updated: 2025-06-03

Locations

3 sites across 3 countries: Canada, Italy, Spain