Cara CDRM (Conduction Disturbance Risk Monitor) 2.0

Stopped early · Not applicable

Conditions studied: Transcatheter Aortic Valve Replacement

In brief

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.

Key facts

Study ID

NCT05465655

Run by

Cara Medical Ltd

People needed

33

Starts

2022-09-09

Expected to finish

2025-05-31

Last updated by the study team

2025-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must meet be ≥ 18 years of age.
• Must meet indications for TAVR using approved devices
• Provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
• Willing to comply with specified follow-up evaluations.
• Must meet the legal minimum age to provide Informed Consent based on local regulatory requirements.

You may not qualify if…

• Any implanted device or an indication for treatment with rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) at baseline.
• Any contraindication to the TAVR procedure according to the instructions for use.
• Less than the legal age of consent, legally incompetent, or otherwise vulnerable.
• Planned treatment with any other investigational device, drug, or procedure (excluding registries) during the study period.

Where it is running

• Mackram F. Eleid, M.D. — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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