Cara CDRM (Conduction Disturbance Risk Monitor) 2.0

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Mackram Eleid, M.D.

Abierto para la inscripción

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publicaciones

Publications are currently not available