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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.
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
Procedure
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECG Monitoring -TAVR patients | Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECG monitoring | Device | Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure |
|
| 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:
| 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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600 patients undergoing TAVR will be enrolled at the investigational sites.
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| Name | Affiliation | Role |
|---|---|---|
| Helena Grinberg-Rashi, PhD | helenag@k2-medicalltd.com | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval | Québec | Canada | ||||
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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| Policlinico San Donato |
| Milan |
| 20097 |
| Italy |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |