MediCool Protocol
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-002221
NCT ID: NCT05324540
Sponsor Protocol Number: FIH-001 Revision A
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.
- Significant intra-cardiac thrombus
- Subjects not eligible for or considered high risk for anticoagulation
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 Juan Crestanello, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available