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

Overview

About this study

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

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:

  • 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).

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

Rochester, Minn.

Mayo Clinic principal investigator

Thomas Munger, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20306550

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