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The purpose of this study is to estimate left atrial volume reduction surgery concomitant with the maze procedure and mitral valve repair/replacement in patients with atrial fibrillation with an enlarged left atria.
The Cox-Maze procedure has been a gold standard for the treatment of atrial fibrillation. Success of the modified maze procedure after valvular operation with an enlarged left atria and persistent and longstanding persistent atrial fibrillation remains suboptimal. The question addressed was: In adults undergoing a maze procedure for atrial fibrillation does left atrial size reduction compared to maze surgery alone improve maze surgery success?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MVS + maze | Active Comparator | Procedure: Maze procedure, mitral valve surgery The scheme of lesion pattern: "box" lesion + line to mitral valve + line from "box" to left atrial appendage. The ablation procedure was performed by using a dry bipolar radiofrequency ablation clamp. The left atrial appendage was excluded in all cases. For mitral regurgitation or stenosis, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, a valve replacement will be performed. |
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| MVS + maze + LA reduction | Experimental | Procedure: maze procedure, mitral valve surgery, left atrial reduction The scheme of lesion pattern: "box" lesion + line to mitral valve + line from "box" to left atrial appendage. The ablation procedure was performed by using a dry bipolar radiofrequency ablation clamp. The left atrial appendage was excluded in all cases. For mitral regurgitation or stenosis, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, a valve replacement will be performed. The enlarged left atria are plicated (suture technique) between the left and right pulmonary vein down to the inferior end of left atrial incision on the half-moon shape. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maze procedure | Procedure | The scheme of lesion pattern: "box" lesion + line to mitral valve + line from "box" to left atrial appendage. The ablation procedure was performed by using a dry bipolar radiofrequency ablation clamp. The left atrial appendage was excluded in all cases. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial fibrillation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of significant adverse events | 12 months |
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Inclusion Criteria:
Duration of AF must be documented by medical history and Presence of AF must be documented by a direct electrocardiographic assessment within 6 months prior to randomization.
b) 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 OR.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander V Bogachev-Prokophiev, PhD | Meshalkin Research Institute of Pathology of Circulation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novosibirsk State Research Institute of Circulation Pathology | Novosibirsk | 630055 | Russia |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000079042 | Maze Procedure |
| D000078703 | Radiofrequency Ablation |
| D058386 | Mitral Valve Annuloplasty |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
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| mitral valve surgery | Procedure | For mitral regurgitation or stenosis, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, a valve replacement will be performed. |
|
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| left atrial reduction | Procedure | The enlarged left atria are plicated (suture technique) between the left and right pulmonary vein down to the inferior end of left atrial incision on the half-moon shape. |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D019616 | Thoracic Surgical Procedures |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D058385 | Cardiac Valve Annuloplasty |