Completed

NCT Number: NCT05657912

Cara CDRS (Conduction Disturbance Risk Score) 1.0

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.

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Key information

Conditions

Transcatheter Aortic Valve Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

About this study

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:

Pre-procedure

Demographics
Medical history
Cardiac CT
12 lead ECG
Procedure

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

Post-procedure (discharge)

a. 12 lead ECG

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ECG monitoring

Device

Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure

Primary outcomes

Estimated reduction of New Onset Conduction Disturbances NOCD (percentage) at 14 days post TAVR while using Cara Monitor

Time frame: 14 days
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-)

Sponsors and collaborators

Lead sponsor

Cara Medical Ltd

Industry

Registry information

Official study title

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).

Acronym: CDRS

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Dec 20, 2022
Registry last updated: Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed