MediCool Protocol

Overview

About this study

The purpose of this study is to assess termination of atrial fibrillation (AF) following delivery of cold treatment to the oblique sinus using an experimental cooling module.

 

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:

  • Subject must be ≥ 18 years or older.
  • Male or female.
  • Subject has documented paroxysmal, or persistent atrial fibrillation (AF) with a history of less than one-year duration.
  • Must be in AF at time of surgery, or inducible using manual or electrical stimulation.
  • Subject is willing and able to provide written informed consent.
  • Subject has a life expectancy of at least 1 year.

Exclusion Criteria:

  • Long-standing AF (duration > 1 year).
  • Prior AF ablation.
  • Left main coronary artery occlusion > 70%.
  • Critical aortic stenosis (gradient > 50mm HG).
  • Inability to induce patient into AF without drugs at time of surgery.
  • Female subjects who are pregnant at time of surgery.
  • Subjects with a medical condition or comorbidity that could adversely impact study participation, safety or conduct of the study.
  • Permanent pacemaker or implantable cardioverter defibrillator.
  • Current cancer treatment that includes radiation of the heart.
  • Inability to give informed consent.

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

Juan Crestanello, M.D.

Contact us for the latest status

Contact information:

Deborah Rolbiecki

(507) 255-5027

rolbiecki.deborah@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20516783

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