Cara CDRM (Conduction Disturbance Risk Monitor) 2.0 (Cara CDRM)

Pilot Study to Estimate a Reduction of TAVR Associated Conduction Disturbance Through Notification of Cara Monitor During TAVR Procedure

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.

Study Overview

• Status: Recruiting
• Conditions: Transcatheter Aortic Valve Replacement
• Intervention / Treatment: Other: ECG monitoring for Conduction Disturbances

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

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helena Grinberg, PhD; Phone Number: +31615636666; Email: helenag@k2-medicalltd.com

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mackram F. Eleid, M.D.
      • Contact: Grace Wronski; Phone Number: 507-255-5782; Email: Wronski.Grace@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: ECG monitoring for Conduction Disturbances; Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure; Other Names: Continues ECG monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Cara performance in reduction of New Onset Conduction Disturbances (NOCD)	Estimate the reduction of NOCD (percentage) at 14 days post TAVR while using Cara Monitor	14 days
Evaluate Cara performance in reduction of Permanent Pacemaker (PPM) or High-Grade AV Block (HGAVB)	Estimate the reduction (a percentage) of PPM or High-Grade AV Block (HGAVB)	14 days
Evaluate Cara usability using a dedicated questioner	Estimate learning curve of using CaraTM system (e.g. the experience required with system for achieving above improvements)	1 Day of Procedure
Evaluate Cara Safety, collecting Adverse Events	During the study patients will be followed for any adverse events relevant to the TAVR procedure as defined in the CRF	14 days

Collaborators and Investigators

• Sponsor: Cara Medical Ltd
• Investigators: Study Chair: Helena Grinberg, PhD, Cara Medical Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2022
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Cara 2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No