Cara CDRS (Conduction Disturbance Risk Score) 1.0

Launched by CARA MEDICAL LTD · Dec 19, 2022

Keywords

ClinConnect Summary

The Cara CDRS 1.0 clinical trial is studying a new way to assess the risk of heart rhythm problems in patients undergoing a procedure called Transcatheter Aortic Valve Replacement (TAVR). These heart rhythm issues can sometimes lead to the need for a pacemaker or cause other complications, which may increase the chances of further health problems. In this trial, researchers will collect heart monitoring data (ECG) from 600 patients before, during, and after their TAVR procedure to see how well the Cara Conduction Disturbance Risk Score (CDRS) can predict these risks.

To be eligible for the study, participants must be at least 18 years old, meet the requirements for having a TAVR procedure, and agree to follow-up evaluations. They should not already have devices like pacemakers or have other health issues that would prevent them from safely undergoing the TAVR procedure. Participants in the trial will not receive any special treatments; instead, their heart data will be analyzed after the procedure to help improve understanding of heart rhythm risks associated with TAVR. This study aims to gather important information that could help doctors better manage patients' care in the future.

Gender

ALL

Eligibility criteria

• 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.

Trial Officials