Clinical trial NCT05657912: Cara CDRS (Conduction Disturbance Risk Score) 1.0
Official 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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transcatheter Aortic Valve Replacement
Lead sponsor: Cara Medical Ltd
Sponsor class: INDUSTRY
First posted: 2022-12-20
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 600 patients undergoing TAVR will be enrolled at the investigational sites.

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Estimated reduction of New Onset Conduction Disturbances NOCD (percentage) at 14 days post TAVR while using Cara Monitor
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
city: Milano
country: Italy
facility: Policlinico San Donato
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: helenag@k2-medicalltd.com
name: Helena Grinberg-Rashi, PhD
role: STUDY_CHAIR
References: