Post-operative pain management in cardiac and thoracic procedures
Conditions
Interventions
Group 1: This is a non-interventional observational study with no different arms/groups of observation.
The REDUCE Registry is a retrospective and prospective, multicenter, international, , observati
Sponsors
AtriCure
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients have been scheduled by physician(s) to undergo or have undergone cryoablation of the intercostal nerves utilizing at least one AtriCure device or are similar patients treated without the use of cryoablation . EXCEPTION: Participating registry sites that wish to compare AtriCure devices, and their associated procedures’ safety and effectiveness, with other therapies for the management of intra-operative or post-operative pain, can include patients who did not receive treatment with an AtriCure device, but were treated or will be treated for similar baseline disease state. 2. Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
Exclusion criteria
Exclusion criteria: 1. Patient is enrolled in a concurrent trial that may impact the treatment offered by the registry devices. 2. Patient with exclusion criteria required by local governance. 3. Women of childbearing potential who are, or plan to become, pregnant during the time of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary analyses may include, but will not be limited to, the following: CryoNB procedural complications, incidence of death and post-procedural pain. Descriptive statistics will be used for baseline, procedure and follow-up data collected through the study. Time point of data collection according to standard of care. | — |
Countries
Austria, Belgium, France, Germany, United Kingdom, United States
Contacts
Public ContactHauke Winter
Thoraxklinik Universitätsklinikum Heidelberg
Outcome results
None listed