Cara CDRS (Conduction Disturbance Risk Score) 1.0
Study Details
Study Description
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 days FU will be collected.
600 patients will be enrolled in this study the hypothesis that CaraTM can deliver a statistically significant conduction disturbance risk stratification for patients undergoing TAVR.
No investigation intervention is planned during this study. The CaraTM System analysis will be performed off-line.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 the study:
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Pre-procedure
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Demographics
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Cardiac CT (Dicom/disk with raw data ) and analysis 3Menzio
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12 lead ECG
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3-12 lead Holter for at least 1 hour pre procedure
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Procedure
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Continuous 3-12 lead Holter will be supplied by the study sponsor, data will be collected and analyzed by the study sponsor
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Fluoroscopy (captured automatically by video system)
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Hemodynamics (captured automatically by video system)
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Device manufacturer (type) and size
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Post-procedure (in hospital)
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Daily 3-12 lead ECG
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Continuous 3-12 lead Holter
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Post-procedure (after discharge)
- Continuous 1-3 lead Holter for 14 days will be supplied by the study sponsor, the data from the Holter recordings will be collected from the patients home and analyzed by the study sponsor.
Holter recordings will be collected from the patient's home and analyzed by the study sponsor.
- Patients will be followed according to the current medical practice.
The data collected from the study will be used to evaluate the performance CaraTM 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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PPM or High-Grade AV Block (HGAVB)
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All other new onset (or deterioration) of CD that are not listed in #1
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No new onset CD
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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
|
Outcome Measures
Primary Outcome Measures
- Estimated reduction of New Onset Conduction Disturbances NOCD (percentage) at 14 days post TAVR while using Cara Monitor [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-)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Must meet be ≥ 18 years of age.
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Must meet indications for TAVR using approved devices
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Provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
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Willing to comply with specified follow-up evaluations.
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Must meet the legal minimum age to provide Informed Consent based on local regulatory requirements.
Exclusion Criteria:
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Any implanted device or an indication for treatment with rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization
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Therapy with cardioverter-defibrillator (CRT-D) at baseline.
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Any contraindication to the TAVR procedure according to the instructions for use.
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Less than the legal age of consent, legally incompetent, or otherwise vulnerable.
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Planned treatment with any other investigational device, drug, or procedure (excluding registries) during the study period.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- K2 Medical Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Cara 1.0