MedTrace Logo

Cara CDRS (Conduction Disturbance Risk Score) 1.0

NCT05657912 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 355

Last updated 2025-06-03

No results posted yet for this study

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.

Conditions

  • Transcatheter Aortic Valve Replacement

Interventions

DEVICE

ECG monitoring

Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure

Sponsors & Collaborators

  • Cara Medical Ltd

    lead INDUSTRY

Principal Investigators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Canada
  • Italy
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05657912 on ClinicalTrials.gov