Cara CDRM (Conduction Disturbance Risk Monitor) 2.0

NCT ID: NCT05465655

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-09
• Study Completion Date: 2025-05-31

Brief 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.

Detailed Description

Data to be collected during the study procedure for both stages:

1. Pre-procedure:

1. Demographics, medical history, cardiac history, medications

2. Cardiac CT raw data to be collected from all the pre-procedure CT scans performed in Medical Centers and from out-of-hospital sources (if available).

3. In hospital 12 lead ECG

2. Procedure:

During the procedure, the 12 lead ECG will be recorded processed, and displayed on the Cara monitor that is connected to Norav NR-1207-3 ECG Holter System. The Hemodynamic and Fluoroscopy monitors will be recorded on a commercially available video recorder.

3. Post-procedure (in hospital)

1. After the procedure patients will continue to be connected to a commercially available to a commercially available 14 days ambulatory Holter monitor (AEM) (e.g. Bittium Faros™ ; MoMe™ Kardia) and will remain with the patient after the discharge for 14 days.

2. Hospital standard 12 lead ECG will be recorded after the procedure, downloaded and collected by the study team.

4. Post-procedure - out of hospital:

At discharge, patients will stay connected to the ambulatory Holter monitor (AEM) (Bittium Faros™; MoMe™ Kardia ) for 14 days post-procedure. Holter will be collected from patients at the end of the 14-day recording and its data downloaded and collected.

Patients will be followed according to the current medical practice.

5. Follow-up according to the current medical practice a. 30 days follow-up hospital visit: i. Cardiac echo (if available) ii. 12 lead ECG b. 6 month - Clinical FU phone call c. 12 months Clinical FU phone call

Conduction Disturbances (CD) outcome will be subdivided into:

1. PPM or High-Grade AV Block (HGAVB)

2. All other new onset (or deterioration) of CD that are not listed in #1

3. No new onset CD

Conditions

Transcatheter Aortic Valve Replacement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients undergoing TAVR

Study subjects will be studied during the TAVR procedure and their 12 lead ECGs collected and analyzed notifying for New-Onset Conduction Disturbances (NOCD) using Cara Monitor.

Group Type: EXPERIMENTAL

ECG monitoring for Conduction Disturbances

Intervention Type: OTHER

Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure

Interventions

ECG monitoring for Conduction Disturbances

Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure

Intervention Type: OTHER

Other Intervention Names

Continues ECG monitoring

Eligibility Criteria

Inclusion Criteria

1. Must meet be ≥ 18 years of age.

2. Must meet indications for TAVR using approved devices

3. Provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

4. Willing to comply with specified follow-up evaluations.

5. Must meet the legal minimum age to provide Informed Consent based on local regulatory requirements.

Exclusion Criteria

1. 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.

2. Any contraindication to the TAVR procedure according to the instructions for use.

3. Less than the legal age of consent, legally incompetent, or otherwise vulnerable.

4. Planned treatment with any other investigational device, drug, or procedure (excluding registries) during the study period.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cara Medical Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helena Grinberg, PhD

Role: STUDY_CHAIR

Cara Medical Ltd

Locations

Mackram F. Eleid, M.D.

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

Cara 2.0

Identifier Type: -

Identifier Source: org_study_id