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NCT05657912
Cara CDRS (Conduction Disturbance Risk Score) 1.0
Conditions: Transcatheter Aortic Valve Replacement
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 600
Sponsor: K2 Medical Ltd
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.
Eligibility Criteria
Inclusion Criteria:Must meet be ≥ 18 years of age.Must meet indications for TAVR using approved devicesProvided 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 rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy (CRT) or Cardiac ResynchronizationTherapy 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.
Source: ClinicalTrials.gov (NCT05657912). StuddyBuddy aggregates publicly available trial information.