Cara CDRS (Conduction Disturbance Risk Score) 1.0

NCT05657912 | Completed

• 1 other identifier: Cara 1.0
• Study Type: observational
• Target: 355
• Locations: 3 countries
• Sites: 3

Brief Summary

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.

Conditions

Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• 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: 1. Patients who receive PaceMaker (PPM) 14 days following TAVr (PPM+) 2. Patients that do not receive PaceMaker (PPM) 14 days following TAVr (PPM-)

  14 days

Study Arms (1)

ECG Monitoring -TAVR patients

Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure

Device: ECG monitoring

Interventions

ECG monitoring DEVICE

Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure

ECG Monitoring -TAVR patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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 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.

Sponsors & Collaborators

• Cara Medical Ltd: lead

Study Sites (3)

Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval

Québec, Canada

Location

Policlinico San Donato

Milan, 20097, Italy

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Interventions

Electrocardiography, Ambulatory

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Helena Grinberg-Rashi, PhD

  helenag@k2-medicalltd.com

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 20, 2022
• Study Start: December 12, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); ES (1); IT (1)