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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT01680757
Eligibility Criteria:
Inclusion Criteria:
1. Aged ≥ 21 years
2. Diagnosed non-valvular atrial fibrillation
3. Current CHADS2 score \> 2
4. Currently contraindicated to or intolerant of standard anticoagulation therapy (i.e., warfarin, dabigatran, apixaban, and rivaroxaban) due to at least one of the following: history of bleeding or high risk of bleeding; labile INR level (While on anticoagulation therapy, participant had INR results "out of therapeutic range" \> 40% of the time, over a minimum period of 2 months.); non-compliant, unwilling to take, or anticoagulant failure (e.g., TIA or stroke while on anticoagulant therapy).
5. Life expectancy of at least 1 year
6. Willing and able to return and comply with scheduled follow up visits
7. Willing and able to provide written informed consent
Exclusion Criteria:
1. Prior cardiac surgery involving opening of pericardium (e.g., CABG, heart transplantation, valve surgery)
2. Prosthetic heart valve or ring in any position
3. Current NYHA Class IV heart failure symptoms
4. Current right heart failure
5. Myocardial infarction within last 3 months
6. Unstable angina within last 3 months
7. Current cardiogenic shock or hemodynamic instability
8. Current symptomatic carotid disease
9. Need for an intra-aortic balloon pump or intravenous inotropes
10. Embolic stroke within the last 30 days
11. Transient ischemic attack (TIA) within the last 30 days
12. Current diagnosis of active systemic infection
13. eGFR \< 60 mL/min/1.73m2 within last 3 months
14. Current renal failure requiring dialysis
15. ALT or AST level \> 3 times upper level of normal, indicating hepatic failure. (NOTE: normal range provided by local laboratory performing the measurement), based on most recent pre-procedure assessment (within 30 days of study treatment)
16. Current clinical evidence of cirrhosis
17. Any history of thoracic radiation
18. Current use of long term treatment with steroids, not including intermittent use of inhaled steroids for respiratory diseases
19. Diagnosed autoimmune disease known to be associated with pericarditis (i.e., specific connective tissue disorders)
20. Any history of pericarditis
21. Pectus excavatum (clinically defined by treating physician)
22. Severe scoliosis
23. Thrombocytopenia (platelet count \< 100 x 109/L) based on most recent pre-procedure assessment (within 30 days of study treatment)
24. Anemia with hemoglobin concentration of \< 10 g/dL based on most recent pre-procedure assessment (within 30 days of study treatment)
25. Pregnancy or desire to get pregnant within next 12 months.
26. Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this registry
27. Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study
28. Any other criteria, which would make the patient unsuitable to participate in this study as determined by clinical site Principal Investigator (e.g., an uncontrolled drug and/or alcohol addiction)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01680757
Study Brief:
Protocol Section:
NCT01680757