Prospective Registry on User Experience With The Mapping System For Ablation Procedures

Overview

Información sobre este estudio

This is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the United States, Europe and Asia-Pacific Regions.

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:

  • Subjects who are eligible for an ablation procedure with the Rhythmia 3D mapping system and IntellaMap Orion mapping catheter according to current international and local guidelines (and future revisions) and per physician discretion;
  • Subjects who are willing and capable of providing informed consent;
  • Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center;
  • Subjects whose age is 20 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

  • Subjects requiring de novo ablation of atrial fibrillation;
  • Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility*;
  • The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
  • Subjects who have undergone a previous cardiac ablation within 30 days prior to enrollment;
  • Unrecovered/unresolved Adverse Events from any previous invasive procedure;
  • Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).

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

Rochester, Minn.

Investigador principal de Mayo Clinic

Thomas Munger, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20306550

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