Siemens AcuNav Crystal ICE Catheter in Evaluation of Cardiac Anatomy and Physiology During Electrophysiology and Structural Heart Interventional Procedures

Overview

About this study

The purpose of this study is to guide product development for AcuNav Crystal ICE catheters.

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:

  • Be aged above 18 for adult participants
  • Be scheduled for ablation of a supraventricular tachycardia (SVT) or ventricular tachycardia (VT) due to the arrhythmia, poorly tolerated and/or unable to be controlled with antiarrhythmic drug therapy or being scheduled for transcatheter repair of SHD such as ASD/PFO closure, , or LAA occlusion
  • Be able and willing to give informed consent

Exclusion Criteria:

  • subjects who do not have any indication for above mentioned procedures
  • subjects younger than 18 years of age
  • incompetent subjects who cannot provide informed consent
  • subjects from any vulnerable groups other than pediatric patients
  • Pregnant or nursing subjects
  • Subjects who are currently enrolled in any other clinical studies or have been participated in any drug or device studies in last 30 days of current procedure
  • Subjects with any bleeding diathesis
  • Subjects with known vascular abnormality rendering right heart catheterization from right or left femoral vein impossible.
  • Subjects with known intracardiac thrombus
  • Subjects with myocardial infarction within the prior two months
  • Subjects with class IV angina or heart failure
  • Subjects with sepsis or active infection
  • Subjects with immune-deficiency or immune-compromised status
  • Subjects with cerebral ischemic event in the prior six months
  • Subjects with deep vein thrombosis

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/6/2024. 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

Ammar Killu, M.B.B.S.

Contact us for the latest status

Contact information:

CVRU Heart Rhythm Services Research Team

(507) 255-0774

More information

Publications

Publications are currently not available
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CLS-20583110

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