Cara CDRS (Conduction Disturbance Risk Score) 1.0 (CDRS)

A Continuous ECG Monitoring Data Collection Study in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR) to Evaluate the Performance of the Cara Monitor Conduction Disturbance Risk Score (CDRS).

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.

Study Overview

• Status: Recruiting
• Conditions: Transcatheter Aortic Valve Replacement
• Intervention / Treatment: Device: ECG monitoring

Detailed Description

TAVR will be performed using site investigators' best practices including the use of standard-of-care catheters, devices, imaging, and monitoring modalities.

Data will be collected to include the following patients' measures during this study:

1. Pre-procedure

   1. Demographics
   2. Medical history
   3. Cardiac CT
   4. 12 lead ECG

2. Procedure

   1. Continuous 3-12 lead Holter will be supplied, data will be collected and analyzed by the study sponsor
   2. Fluoroscopy (captured automatically by video system )
   3. Device manufacturer (type) and size

3. Post-procedure (in hospital)

   a. Continuous 1-3 lead Holter for 14 days will be supplied, and the data from the Holter recordings will be collected from the patient's home and analyzed.

4. Post-procedure (discharge)

   a. 12 lead ECG

5. Patients will be followed according to the current medical practice.

Data to be collected during the FU :

a. 12 lead ECG at 14/30 days

The data collected from the study will be used to evaluate the performance Cara System, a conduction disturbance monitor that provides an indication of conduction disturbances during TAVR procedures.

Conduction Disturbances (CD) outcome will be subdivided into:

1. PPM or High-Grade AV Block (HGAVB)
2. All other new onsets (or deterioration) of CD that are not listed in #1
3. No new onset CD

• Study Type: Observational
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• Canada
  • Québec, Canada
    • Recruiting
    • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
    • Contact: Josep Rodés-Cabau, MD; Phone Number: +1-418-656-8711
• Italy
  • Milano, Italy, 20097
    • Recruiting
    • Policlinico San Donato
    • Contact: Francesco Bedogni, MD; Email: francesco.bedogni@grupposandonato.it
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona
    • Contact: ANDER REGUEIRO CUEVA, MD; Phone Number: +93 227 54 00; Email: aregueir@clinic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

600 patients undergoing TAVR will be enrolled at the investigational sites.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Any implanted device or an indication for treatment with a 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ECG Monitoring -TAVR patients; Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure	Device: ECG monitoring; Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated reduction of New Onset Conduction Disturbances NOCD (percentage) at 14 days post TAVR while using Cara Monitor	Continuous ECG data collected during the TAVR procedure will be used to retrospectively evaluate the performance of the Cara monitor Conduction Disturbance Risk Score (CDRS) in patients post- TAVR procedure. Measured output: Patients who receive PaceMaker (PPM) 14 days following TAVr (PPM+); Patients that do not receive PaceMaker (PPM) 14 days following TAVr (PPM-)	14 days

Collaborators and Investigators

• Sponsor: Cara Medical Ltd
• Investigators: Study Chair: Helena Grinberg-Rashi, PhD, helenag@k2-medicalltd.com

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Cara 1.0

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.: Yes