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 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT03347695
Eligibility Criteria:
Phase I Inclusion Criteria
1. Able to sign Informed Consent and Release of Medical Information forms
2. Age ≥ 18 years and ≤ 60 years old
3. Clinical indications for only mitral valve surgery for the following:
Organic mitral valve disease without other cardiac disorders (functional or structural).
4. Longstanding persistent AF is defined as continuous AF of greater than one year duration.
Duration of AF must be documented by medical history and Presence of AF must be documented by a direct electrocardiographic assessment upon arrival in the clinic.
5. Able to use heart rhythm monitor
6. Anteroposterior diameter of left atrial between 45mm and 60mm
7. Without history of stroke. Exclusion Criteria
1\. AF without indication for mitral valve surgery; or 2. Ischemic mitral regurgitation with evidence of concomitant structural mitral valve disease; or 3. Functional tricuspid regurgitation; or 4. AF is only or paroxysmal persistent; or 5. Evidence of active infection; or 6. Mental impairment or other conditions that may not allow patient to understand the nature, significance, and scope of study; or 7. Surgical management of hypertrophic obstructive cardiomyopathy; or 8. Previous catheter ablation for AF; or 9. Life expectancy of less than one year; or 10. Absolute contraindications for anticoagulation therapy; or 11. Enrollment in concomitant drug or device trials; or 12. Uncontrolled hypo- or hyperthyroidism; or 13. FEV1 \< 30% of predicted value; or 14. Women who are pregnant as evidenced by positive pregnancy test; or 15. Women of childbearing age who do not agree to be on adequate birth control throughout the period of the trial; or 16. Diagnosed with infective endocarditis; or 17. Need emergency surgery. Phase II Inclusion Criteria
1. Able to sign Informed Consent and Release of Medical Information forms
2. Age ≥ 18 years
3. Clinical indications for mitral valve surgery for the following:
Organic mitral valve disease; or Functional non-ischemic mitral regurgitation; or Ischemic mitral regurgitation with evidence of concomitant structural mitral valve disease.
Note: May include need for surgical management of functional tricuspid regurgitation or patent foramen ovale. May also include concomitant CABG, aortic arch or aortic valve procedure. Surgical intervention may be performed via sternotomy or minimally invasive procedure.
4. Longstanding persistent AF is defined as continuous AF of greater than one year duration.
Duration of AF must be documented by medical history and Presence of AF must be documented by a direct electrocardiographic assessment upon arrival in the clinic.
5. Able to use heart rhythm monitor
Exclusion Criteria
1. AF without indication for mitral valve surgery; or
2. AF is only or paroxysmal persistent; or
3. Evidence of active infection; or
4. Mental impairment or other conditions that may not allow patient to understand the nature, significance, and scope of study; or
5. Surgical management of hypertrophic obstructive cardiomyopathy; or
6. Previous catheter ablation for AF; or
7. Life expectancy of less than one year; or
8. Absolute contraindications for anticoagulation therapy; or
9. Enrollment in concomitant drug or device trials; or
10. Uncontrolled hypo- or hyperthyroidism; or
11. Women who are pregnant as evidenced by positive pregnancy test; or
12. Women of childbearing age who do not agree to be on adequate birth control throughout the period of the trial; or
13. Diagnosed with infective endocarditis; or
14. Need emergency surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03347695
Study Brief:
Protocol Section:
NCT03347695