Transcatheter Aortic Valve Replacement Clinical Trial
— CDRSOfficial 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).
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval | Québec | |
Italy | Policlinico San Donato | Milano | |
Spain | Hospital Clínic de Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Cara Medical Ltd |
Canada, Italy, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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: Patients who receive PaceMaker (PPM) 14 days following TAVr (PPM+) Patients that do not receive PaceMaker (PPM) 14 days following TAVr (PPM-) |
14 days |
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