Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
355 participants
OBSERVATIONAL
2022-12-12
2025-05-31
Brief Summary
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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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Detailed Description
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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
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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ECG Monitoring -TAVR patients
Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure
ECG monitoring
Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure
Interventions
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ECG monitoring
Continuous ECG monitoring of Conduction Disturbances in patients undergoing TAVR procedure
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Cara Medical Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
Québec, , Canada
Policlinico San Donato
Milan, , Italy
Hospital Clínic de Barcelona
Barcelona, , Spain
Countries
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Other Identifiers
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Cara 1.0
Identifier Type: -
Identifier Source: org_study_id
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