Cara CDRM (Conduction Disturbance Risk Monitor) 2.0

Overview

About this study

The purpose of this study is to establish the safety of using Cara™ Monitor used in TAVR, and to estimate the effect of Cara Monitor on reduction of NOCD post TAVR compared to patients treated and followed per regular site-specific practice.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Subject must be ≥ 18 years of age.
Subject meets indications for TAVR using approved devices.
The study patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
Subject is willing to comply with specified follow-up evaluations.
Subject meets the legal minimum age to provide Informed Consent based on local regulatory requirements.

Exclusion Criteria:

Patient with any implanted or have an indication for treatment with 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.
Subject is less than the legal age of consent, legally incompetent, or otherwise vulnerable.
Patients who have a planned treatment with any other investigational device, drug or procedure (excluding registries) during the study period.

Eligibility last updated 6/24/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Mackram Eleid, M.D.	Closed for enrollment	Contact information: Structural Heart Disease Research Coordinators (507) 255-6133

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mackram Eleid, M.D.

Closed for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

Publications are currently not available

Clinical Trials