Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AtriCure, Inc.
Completion of the proposed study will for the first time demonstrate efficacy of intercostal cryoanalgesia in patients undergoing minimally invasive cardiac procedures. Furthermore, results of this study may have a pivotal role in supporting future clinical outcome trials for intercostal cryoanalgesia therapy.
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 18 - 85 years male or female
Patients undergoing unilateral thoracotomy cardiac procedures (with the exception of Aortic Aneurysm repair as sole treatment)
Acceptable surgical candidate, including use of general anesthesia
Willing and able to provide written informed consent
Willing and able to return for scheduled follow-up visits
You may not be if
Cardiac valve surgical procedure via conventional full sternotomy
Procedures that require a posterolateral thoracotomy
Current pregnancy
Current use of prescription opioids
FEV1 \< 40% predicted
Documented myocardial infarction within 30 days of signing Informed Consent Form (ICF)
Documented psychiatric disease
Documented chronic pain syndrome
Documented history of substance abuse
Patient currently enrolled in another research study that could directly affect results of either study
Physical or mental condition that would interfere with patient's self-assessment of pain
