Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT02530203
Eligibility Criteria:
Inclusion Criteria:
1. Patients which will be subjected to an OFF-pump CABG procedure
2. More than 18 years of age
3. Subject is able and willing to give informed consent.
Exclusion Criteria:
1. Patients with known history of atrial arrhythmias.
2. Patients who are not treated with β-blockers unless heart rate is too low for β-blockers assumption.
3. Participation in another clinical trial which may affect the outcome within 3 months prior to day of procedure.
4. Other surgical interventions (e.g. valve replacement) programmed in the same surgical session
5. Resting pulse rate ≤45 beats / min as assessed before daily doses of β-blockage is administered.
6. Hypotension (RR systolic \<100 or RR diastolic \<50).
7. Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complete bundle branch block.
8. Subject is diagnosed with epilepsy or history of seizures.
9. Coagulation abnormalities as determined by anticoagulation guidelines for neuroaxial procedures 2011.
10. Patients not stabilized on an anti-arrhythmic drug regimen for the last 30 days.
11. Patients with long QT syndrome.
12. Patients with Brugada syndrome.
13. Patients affected by Polyneuropathy (e.g. due to diabetes).
14. Patients affected by pericarditis
15. Patients who underwent procedures in the past, which are expected to have changed the innervation of the heart for example:
* Ablation procedure
* Cardiac surgery
16. Pregnant patients or nursing (subjects who are of child bearing potential and are not on a reliable form of birth control will undergo a pregnancy test)
17. Patients already implanted with cardiac devices
18. Patients with existing implanted neurostimulators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02530203
Study Brief:
Protocol Section:
NCT02530203