Research & Innovation

EnSite Precision

Clinical Trials

SLUHN 2018-75

EnSite Precision Observational Study:  A Clinical Evaluation using EnSite Precision Cardiac Mapping System (software version 2.0.1 or higher) in a Real-World Environment

Physician & Study Coordinator

Study Coordinator

Susan Hahn

484-526-7825

susan.hahn2@sluhn.org

Close

Synopsis

Synopsis: The purpose of this clinical study is to evaluate the clinical usage of the EnSite Precision™ Cardiac Mapping System and the new software in a variety of procedures and clinical settings. The system is approved for use worldwide, so there are no parts of this study that would be considered experimental.

In order to assess this new and improved system, the information and data coming from your procedure and follow-up period will be collected and analyzed. Your doctor will treat your heart rhythm disorder as per normal standard practice in your hospital. There will be no change to your ablation procedure; however, there might be a small change to your long-term follow-up. Depending on your doctor’s standard follow-up practice, you might be invited one or two times more for an in-clinic visit throughout the study follow-up period.

Information collected during the course of this study will include data about your overall heart condition, the catheter ablation procedure and how you do after the procedure. You will also be asked some questions about how you are feeling physically and emotionally.

Close

Inclusion Criteria
  • Indicated for a cardiac EP mapping and RF ablation procedure using a 3D mapping system per IFU
  • Over 18 years of age
  • Able to provide informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule

Close

Exclusion Criteria
  • Patients who are only presenting with:
    • Atrioventricular Nodal Reentrant Tachycardia (AVNRT)
    • Atrioventricular Reentrant Tachycardia (AVRT)
  • Planned cryoablation procedure
  • Implanted with a neurostimulator
  • Contraindication to anticoagulation
  • Known presence of cardiac thrombus
  • Recent (<3 months) myocardial infarction or unstable angina or coronary artery by-pass
  • Currently enrolled in a clinical study/investigation evaluating another device or drug that would confound the results of this study
  • Pregnant or nursing
  • Individuals whose willingness to volunteer in a study, in the judgement of investigator or public authorities, could be unduly influenced by lack of or loss of the autonomy due to immaturity, or mental disability, or adverse personal circumstances, or hierarchical influence

Close