Status:
COMPLETED
A New Operation for the Treatment for Long-standing Atrial Fibrillation
Lead Sponsor:
Fujian Medical University
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Atrial fibrillation(AF) often occurs in patients with mitral valve disease. Both mitral replacement and mitral valve plasty are the effective methods to the mitral valve disease. How to cure atrial fi...
Detailed Description
From September 2017, 20 selective patients, and then 120 consecutive patients with valvular atrial fibrillation were treated with our new operation. If the clinical results from the first 20 patients ...
Eligibility Criteria
Inclusion
- Phase I Inclusion Criteria
- Able to sign Informed Consent and Release of Medical Information forms
- Age ≥ 18 years and ≤ 60 years old
- Clinical indications for only mitral valve surgery for the following:
- Organic mitral valve disease without other cardiac disorders (functional or structural).
- 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.
- Able to use heart rhythm monitor
- Anteroposterior diameter of left atrial between 45mm and 60mm
- 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
- Able to sign Informed Consent and Release of Medical Information forms
- Age ≥ 18 years
- 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.
- 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.
- Able to use heart rhythm monitor
- Exclusion Criteria
- AF without indication for mitral valve surgery; or
- AF is only or paroxysmal persistent; or
- Evidence of active infection; or
- Mental impairment or other conditions that may not allow patient to understand the nature, significance, and scope of study; or
- Surgical management of hypertrophic obstructive cardiomyopathy; or
- Previous catheter ablation for AF; or
- Life expectancy of less than one year; or
- Absolute contraindications for anticoagulation therapy; or
- Enrollment in concomitant drug or device trials; or
- Uncontrolled hypo- or hyperthyroidism; or
- Women who are pregnant as evidenced by positive pregnancy test; or
- Women of childbearing age who do not agree to be on adequate birth control throughout the period of the trial; or
- Diagnosed with infective endocarditis; or
- Need emergency surgery.
Exclusion
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03347695
Start Date
September 1 2017
End Date
March 1 2021
Last Update
October 29 2021
Active Locations (1)
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1
Department of Cardiovascular Surgery,Union Hospital
Fuzhou, Fujian, China, 350001