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Cara CDRM (Conduction Disturbance Risk Monitor) 2.0

NCT05465655 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-06-04

No results posted yet for this study

Summary

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.

Conditions

  • Transcatheter Aortic Valve Replacement

Interventions

OTHER

ECG monitoring for Conduction Disturbances

Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure

Sponsors & Collaborators

  • Cara Medical Ltd

    lead INDUSTRY

Principal Investigators

  • Helena Grinberg, PhD · Cara Medical Ltd

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-09
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • United States

Study Locations

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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 NCT05465655 on ClinicalTrials.gov