N/A
N=140
A New Operation for the Treatment for Long-standing Atrial Fibrillation
Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT03347695 ↗Enrolled (actual)
140
Serious AEs
17.9%
Results posted
Oct 2021
Primary outcome: Primary: Numbers of Participants Free From AF — 20; 96; 20; 97 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients) (Procedure); Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fujian Medical University
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numbers of Participants Free From AF |
20; 96; 20; 97; 20; 97 | — |
| PRIMARY Intraoperative Cardiopulmonary Bypass Duration |
44.4; 52.5 | — |
| PRIMARY The Adverse Events Within 30 Days After Surgery |
0; 2; 0; 1; 0; 1 | — |
| SECONDARY Change in Left Atrial Anteroposterior Diameter |
37.0; 39.6; 36.8; 39.2 | — |
| SECONDARY Change in Left Atrial Transversal Diameter |
40.5; 42.1; 40.3; 42.5 | — |
| SECONDARY Change in Left Atrial Superoinferior Diameter |
50.3; 54.7; 50.3; 55.7 | — |
| SECONDARY The Number of Participants Who Will be Detected the Peak Late Trans-mitral Flow Velocity (A Wave) Reappearance |
18; 80; 18; 84 | — |
| SECONDARY MACEs Within 12 Months After Surgery |
0; 2; 0; 3; 0; 1 | — |
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 fibrillation is the key to full recovery. Radiofrequency ablation (RFA) in surgery is an effective treatment for those patients. But there are some recurrence rate after RFA, particularly in patients with enlarged left atrium. So the investigators design a new procedure(Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure) during mitral surgery and study the outcomes to evaluate this new operation.
Eligibility Criteria
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
- 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.
Data sourced from ClinicalTrials.gov (NCT03347695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.