ANOLAF: A New Operation for the Treatment for Long-standing Atrial Fibrillation

• Sponsor: Fujian Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03347695
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Arms: 2
• Actual Duration (Months): 42
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Procedure: 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	N/A

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 with restrict selection criteria are unsatisfied, that is, the restoration rate of the sinus rhythm was less than 50% at 1-year follow up, the study will be stopped. Otherwise, another single arm with 120 consecutive patients with valvular AF will be recruited for next phase.

Procedure details: All patients will have their left atrial geometric volume reduced, pulmonary vein island isolated and left appendage ligated or suture closed. After the superior vena cava was transected, two circular incisions were usually made in the left atrial wall between the pulmonary veins and the mitral annulus for circumferential atrial strip resection and pulmonary vein island isolation. The first circular incision was performed around the pulmonary veins. With this incision, pulmonary vein island was isolated and the left atrium was opened. The second one was performed in the interatrial groove and extended around the mitral annulus, leaving a 2 cm inferior wall margin from the annulus and the appendage in situ. With those two incisions, a circumferential strip of the left atrium was excised. Then the base of the left atrial appendage was ligated or excised and sutured. After the mitral manipulations, the center of the pulmonary vein island was longitudinally reef-imbricated with a 3-0 polypropylene continuous running suture to exclude toward the outside of the left atrial cavity. This plicated pulmonary vein island was directly anastomosed to the resected margin around the mitral annulus and the intraatrial septum instead of the interatrial groove. Finally, caval continuity was restored after aortic cross-clamp removal using a running 4-0 polypropylene suture.

Telephone contact was maintained with the patients after discharge.The use of antiarrhythmic medications will be allowed during the first 3 months(blanking period). Transthoracic 2-dimensional echocardiography and Holter monitoring will be obtained at baseline and at 3, 6, and 12 months after the initial operation. Whenever the participants have symptoms such as palpitation, dizziness, or shortness of breath, they could telephone the doctors.

The primary efficacy endpoint is freedom from AF at both 6 months and 12 months after surgery, assessed by 7-days continuous Holter monitoring. The primary safety are cardiopulmonary bypass time; and a composite of death, stroke, serious cardiac events (heart failure, myocardial infarction), cardiac re-hospitalizations, transient ischemic attack, pulmonary embolism, peripheral embolism, coronary artery injury, anatomical excessive bleeding, deep sternal wound infection/mediastinitis, damage to specialized conduction system requiring permanent pacemaker, and superior vena cava stenosis, within 30 days after the procedure or hospital discharge (whichever was later) The secondary efficacy endpoint are the left atrial linear dimensions and A wave reappearance measured by transthoracic echocardiography at 3 time points (before surgery, 6 and 12 months after surgery). The secondary safety endpoint are Major adverse cardiac events, which were defined as a non-weighted composite score of: death, stroke, worsening heart failure (+1 NYHA Class), hospitalization for heart failure, and mitral valve re-intervention within 12 months after surgery; and incidence of protocol-defined serious adverse events (especially thromboembolic and hemorrhagic events) within 12 months after surgery. Statistical analysis were performed with statistic package for social science( SPSS) 11.5 software. A value of P < 0.05 was considered statistically significant.

Study Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A New Operation (Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure) for the Treatment of Long Standing Persistent Atrial Fibrillation (AF) During Mitral Valve Surgery
• Actual Study Start Date: Sep 1, 2017
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A new operation Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure	Procedure: Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients); Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
Other: A new operation (Selected pilot study) Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure	Procedure: Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure; Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure

Outcome Measures

Primary Outcome Measures

1. Numbers of Participants Free From AF [3, 6, and 12 months after the operation]

   Freedom from AF in patients with longstanding persistent AF undergoing MVS at 6 months and 12 months. AF will be measured by 7 days continuous Holter monitoring at 6 months and 12 months post-surgery; and freedom of AF will be defined by absence of AF lasting > 30 seconds at 12 months

2. Intraoperative Cardiopulmonary Bypass Duration [1 hour after operation]

   Cardiopulmonary bypass (CPB) technology is used in most cardiovascular surgeries. These surgeries utilize CPB, which has been associated with some adverse effects. This is most likely due to exposure of blood to abnormal surfaces and conditions leading to systemic inflammatory responses. Prolonged CPB duration is associated with worse clinical outcomes.

3. The Adverse Events Within 30 Days After Surgery [Within 30 days after surgery]

   The adverse events within 30 days after surgery, including: death, stroke, serious cardiac events (heart failure, myocardial infarction), cardiac re-hospitalizations, transient ischemic attack, pulmonary embolism, peripheral embolism, coronary artery injury, anatomical excessive bleeding, deep sternal wound infection/mediastinitis, damage to specialized conduction system requiring permanent pacemaker, and superior vena cava stenosis.

Secondary Outcome Measures

1. Change in Left Atrial Anteroposterior Diameter [6 months and 12 months post-surgery]

   echocardiographic change in left atrial anteroposterior diameter

2. Change in Left Atrial Transversal Diameter [6 months and 12 months post-surgery]

   echocardiographic change in left atrial transversal diameter

3. Change in Left Atrial Superoinferior Diameter [6 months and 12 months post-surgery]

   echocardiographic change in left atrial superoinferior diameter

4. The Number of Participants Who Will be Detected the Peak Late Trans-mitral Flow Velocity (A Wave) Reappearance [6 months and 12 months post-surgery]

   The peak late trans-mitral flow velocity (A wave) reappearance means recover of efficient left atrial contraction which indicates lower rate of thrombosis. Usually these is no A wave for AF patients. The peak late trans-mitral flow velocity 6 months and 12 months post-surgery, which will be measured by transthoracic echocardiography.

5. MACEs Within 12 Months After Surgery [Within 12 months]

   MACEs within 12 months after surgery: defined as a non-weighted composite score of: death, stroke, worsening heart failure (+1 NYHA Class), CHF hospitalization, and mitral valve [MV] re-intervention.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

1. 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.

1. Able to use heart rhythm monitor

2. Anteroposterior diameter of left atrial between 45mm and 60mm

3. Without history of stroke. Exclusion Criteria

4. 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

5. Able to sign Informed Consent and Release of Medical Information forms

6. Age ≥ 18 years

7. 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.

1. 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.

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiovascular Surgery,Union Hospital	FuZhou	Fujian	China	350001

Sponsors and Collaborators

• Fujian Medical University

Investigators

• Study Director: Liangwan Chen, M.D, Union Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 1, 2018
• Informed Consent Form: Informed Consent Form for phase1 - Sep 1, 2017
• Informed Consent Form: Informed Consent Form for phase2 - Aug 1, 2018

More Information

Publications

• Baek MJ, Na CY, Oh SS, Lee CH, Kim JH, Seo HJ, Park SW, Kim WS. Surgical treatment of chronic atrial fibrillation combined with rheumatic mitral valve disease: Effects of the cryo-maze procedure and predictors for late recurrence. Eur J Cardiothorac Surg. 2006 Nov;30(5):728-36. Epub 2006 Sep 26.
• Kim JH, Na CY, Lee SJ, Oh SS. Circumferential left atrium resection for treating a giant left atrium. J Card Surg. 2013 Mar;28(2):102-8. doi: 10.1111/jocs.12061. Epub 2013 Jan 29.
• Kong MH, Lopes RD, Piccini JP, Hasselblad V, Bahnson TD, Al-Khatib SM. Surgical Maze procedure as a treatment for atrial fibrillation: a meta-analysis of randomized controlled trials. Cardiovasc Ther. 2010 Oct;28(5):311-26. doi: 10.1111/j.1755-5922.2010.00139.x. Review.
• Kuck KH, Brugada J, Fürnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
• Kumar P, Athanasiou T, De L Stanbridge R. Treatment of long-duration atrial fibrillation by modified maze procedure. J R Soc Med. 2002 Nov;95(11):552-3.
• Shi J, Bai ZX, Zhang BG, Ren WJ, Guo YQ. A modified Cox maze IV procedure: a simpler technique for the surgical treatment of atrial fibrillation. Interact Cardiovasc Thorac Surg. 2016 Dec;23(6):856-860. Epub 2016 Aug 11.
• Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.
• Zheng S, Zhang H, Li Y, Han J, Jia Y, Meng X. Comparison of Left Atrial and Biatrial Maze Procedure in the Treatment of Atrial Fibrillation: A Meta-Analysis of Clinical Studies. Thorac Cardiovasc Surg. 2016 Dec;64(8):661-671. Epub 2015 Jul 28. Review.

• Responsible Party: Liang-Wan Chen MD, The director of the department of cardiovascular surgery, Fujian Medical University
• ClinicalTrials.gov Identifier: NCT03347695
• Other Study ID Numbers: CLW2017AF
• First Posted: Nov 20, 2017
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Liang-Wan Chen MD, The director of the department of cardiovascular surgery, Fujian Medical University: atrial fibrillation; surgery
• Additional relevant MeSH terms: Atrial Fibrillation; Cardiovascular Diseases

Study Results

Participant Flow

Arm/Group Title	A New Operation (Selected Pilot Study)	A New Operation
Arm/Group Description	Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.	Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
Period Title: Overall Study
STARTED	20	120
COMPLETED	20	115
NOT COMPLETED	0	5

Baseline Characteristics

Arm/Group Title	A New Operation (Selected Pilot Study)	A New Operation	Total
Arm/Group Description	Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.	Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.	Total of all reporting groups
Overall Participants	20	120	140
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	20 100%	113 94.2%	133 95%
>=65 years	0 0%	7 5.8%	7 5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.3 (9.6)	52.3 (8.0)	51.9 (8.2)
Sex: Female, Male (Count of Participants)
Female	13 65%	74 61.7%	87 62.1%
Male	7 35%	46 38.3%	53 37.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	20 100%	120 100%	140 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
China	20 100%	120 100%	140 100%
Hypertension (Count of Participants)
Count of Participants [Participants]	1 5%	13 10.8%	14 10%
Prior stroke (Count of Participants)
Count of Participants [Participants]	0 0%	12 10%	12 8.6%
Diabetes (Count of Participants)
Count of Participants [Participants]	1 5%	5 4.2%	6 4.3%
Smoking History (Count of Participants)
Count of Participants [Participants]	2 10%	25 20.8%	27 19.3%
NYHA Class III or Class IV (Count of Participants)
Count of Participants [Participants]	20 100%	112 93.3%	132 94.3%
Long-standing persistent AF (Count of Participants)
Count of Participants [Participants]	20 100%	120 100%	140 100%
Atrial fibrillation duration (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	19.4 (6.5)	23.6 (9.7)	23.0 (9.4)
EuroScore (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.8 (1.6)	1.8 (1.4)	1.8 (1.4)
Preoperative amiodarone intake (Count of Participants)
Count of Participants [Participants]	1 5%	3 2.5%	4 2.9%
Preoperative Digoxin intake (Count of Participants)
Count of Participants [Participants]	11 55%	69 57.5%	80 57.1%
Preoperative beta-blocker intake (Count of Participants)
Count of Participants [Participants]	5 25%	23 19.2%	28 20%
Preoperative NT-proBNP level (pg/ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pg/ml]	1555.3 (1233.2)	1482.3 (1321.8)	1493.0 (1305.0)
Preoperative creatine level (μmol/l) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [μmol/l]	77.5 (16.3)	79.4 (44.9)	79.1 (42.0)
left ventricular diastolic diameter (milimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milimeters]	48.7 (7.0)	49.7 (7.5)	49.6 (7.4)
left ventricular systolic diameter (milimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milimeters]	34.0 (5.7)	33.6 (5.7)	33.7 (5.7)
left ventricular ejection fraction (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	57.1 (8.1)	60.5 (8.7)	60.0 (8.7)
left atrial anteroposterior diameter (milimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milimeters]	55.0 (3.3)	54.8 (9.3)	54.9 (8.7)
left atrial transversal diameter (milimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milimeters]	59.4 (6.3)	59.6 (13.1)	59.6 (12.4)
left atrial superoinferior diameter (milimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milimeters]	68.9 (6.3)	72.0 (15.4)	71.5 (14.5)
Mitral Lesion (Count of Participants)
Count of Participants [Participants]	20 100%	120 100%	140 100%
Aortic Lesion (Count of Participants)
Count of Participants [Participants]	0 0%	58 48.3%	58 41.4%
Tricuspid Lesion (Count of Participants)
Count of Participants [Participants]	0 0%	85 70.8%	85 60.7%
Coronary Heart Disease (Count of Participants)
Count of Participants [Participants]	0 0%	3 2.5%	3 2.1%
mitral valve procedure (Count of Participants)
mitral valve replacement	20 100%	109 90.8%	129 92.1%
mitral valve repair	0 0%	11 9.2%	11 7.9%
aortic valve replacement (Count of Participants)
Count of Participants [Participants]	0 0%	35 29.2%	35 25%
Tricuspid valve repair (Count of Participants)
Count of Participants [Participants]	0 0%	38 31.7%	38 27.1%
Concomitant CABG (Count of Participants)
Count of Participants [Participants]	0 0%	3 2.5%	3 2.1%
Total surgery time (minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes]	221.6 (33.9)	230.7 (48.4)	229.4 (46.6)
aortic cross-clamp duration (minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes]	44.4 (17.8)	52.5 (23.5)	51.4 (22.9)
Total cardiopulmonary bypass time (minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes]	95.5 (19.0)	106.8 (33.4)	105.2 (31.9)

Outcome Measures

1. Primary Outcome

Title	Numbers of Participants Free From AF
Description	Freedom from AF in patients with longstanding persistent AF undergoing MVS at 6 months and 12 months. AF will be measured by 7 days continuous Holter monitoring at 6 months and 12 months post-surgery; and freedom of AF will be defined by absence of AF lasting > 30 seconds at 12 months
Time Frame	3, 6, and 12 months after the operation

Outcome Measure Data

Analysis Population Description

Twenty patients were enrolled in pilot study and 120 patients were enrolled in latter prospective study.

Arm/Group Title	A New Operation (Selected Pilot Study)	A New Operation
Arm/Group Description	Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)	Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
Measure Participants	20	120
at discharge	20 100%	96 80%
3 months after the operation	20 100%	97 80.8%
6 months after the operation	20 100%	97 80.8%
12 months after the operation	20 100%	98 81.7%

2. Primary Outcome

Title	Intraoperative Cardiopulmonary Bypass Duration
Description	Cardiopulmonary bypass (CPB) technology is used in most cardiovascular surgeries. These surgeries utilize CPB, which has been associated with some adverse effects. This is most likely due to exposure of blood to abnormal surfaces and conditions leading to systemic inflammatory responses. Prolonged CPB duration is associated with worse clinical outcomes.
Time Frame	1 hour after operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A New Operation (Selected Pilot Study)	A New Operation
Arm/Group Description	Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.	Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
Measure Participants	20	120
Mean (Standard Deviation) [minutes]	44.4 (17.8)	52.5 (23.5)

3. Primary Outcome

Title	The Adverse Events Within 30 Days After Surgery
Description	The adverse events within 30 days after surgery, including: death, stroke, serious cardiac events (heart failure, myocardial infarction), cardiac re-hospitalizations, transient ischemic attack, pulmonary embolism, peripheral embolism, coronary artery injury, anatomical excessive bleeding, deep sternal wound infection/mediastinitis, damage to specialized conduction system requiring permanent pacemaker, and superior vena cava stenosis.
Time Frame	Within 30 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A New Operation (Selected Pilot Study)	A New Operation
Arm/Group Description	Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.	Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
Measure Participants	20	120
death	0 0%	2 1.7%
stroke	0 0%	1 0.8%
serious cardiac events (heart failure, myocardial infarction)	0 0%	1 0.8%
deep sternal wound infection/mediastinitis	0 0%	1 0.8%
transient ischemic attack, pulmonary embolism, peripheral embolism	0 0%	0 0%
coronary artery injury	0 0%	0 0%
anatomical excessive bleeding	0 0%	0 0%
damage to specialized conduction system requiring permanent pacemaker	0 0%	0 0%

4. Secondary Outcome

Title	Change in Left Atrial Anteroposterior Diameter
Description	echocardiographic change in left atrial anteroposterior diameter
Time Frame	6 months and 12 months post-surgery

Outcome Measure Data

Analysis Population Description

Twenty patients were enrolled in pilot study and 120 patients were enrolled in latter prospective study. Two of 120 patients died in 30d after surgery，leaving 118 patients to be included in this cohort.

Arm/Group Title	A New Operation (Selected Pilot Study)	A New Operation
Arm/Group Description	Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.	Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
Measure Participants	20	118
6 months post-surgery	37.0 (3.0)	39.6 (6.7)
12 months post-surgery	36.8 (3.1)	39.2 (6.7)

5. Secondary Outcome

Title	Change in Left Atrial Transversal Diameter
Description	echocardiographic change in left atrial transversal diameter
Time Frame	6 months and 12 months post-surgery

Outcome Measure Data

Analysis Population Description

Twenty patients were enrolled in pilot study and 120 patients were enrolled in latter prospective study. Two of 120 patients died in 30d after surgery，leaving 118 patients to be included in this cohort.

Arm/Group Title	A New Operation (Selected Pilot Study)	A New Operation
Arm/Group Description	Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)	Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
Measure Participants	20	118
6 months post-surgery	40.5 (4.6)	42.1 (7.6)
12 months post-surgery	40.3 (4.7)	42.5 (7.7)

6. Secondary Outcome

Title	Change in Left Atrial Superoinferior Diameter
Description	echocardiographic change in left atrial superoinferior diameter
Time Frame	6 months and 12 months post-surgery

Outcome Measure Data

Analysis Population Description

Twenty patients were enrolled in pilot study and 120 patients were enrolled in latter prospective study. Two of 120 patients died in 30d after surgery，leaving 118 patients to be included in this cohort.

Arm/Group Title	A New Operation (Selected Pilot Study)	A New Operation
Arm/Group Description	Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)	Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
Measure Participants	20	118
6 months post-surgery	50.3 (3.6)	54.7 (8.2)
12 months post-surgery	50.3 (3.8)	55.7 (8.4)

7. Secondary Outcome

Title	The Number of Participants Who Will be Detected the Peak Late Trans-mitral Flow Velocity (A Wave) Reappearance
Description	The peak late trans-mitral flow velocity (A wave) reappearance means recover of efficient left atrial contraction which indicates lower rate of thrombosis. Usually these is no A wave for AF patients. The peak late trans-mitral flow velocity 6 months and 12 months post-surgery, which will be measured by transthoracic echocardiography.
Time Frame	6 months and 12 months post-surgery

Outcome Measure Data

Analysis Population Description

Twenty patients were enrolled in pilot study and 120 patients were enrolled in latter prospective study. Two of 120 patients died in 30d after surgery，leaving 118 patients to be included in this cohort.

Arm/Group Title	A New Operation (Selected Pilot Study)	A New Operation
Arm/Group Description	Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)	Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
Measure Participants	20	118
peak late trans-mitral flow velocity (A) reappearance rate 6 months post-surgery	18 90%	80 66.7%
peak late trans-mitral flow velocity (A) reappearance rate 12 months post-surgery	18 90%	84 70%

8. Secondary Outcome

Title	MACEs Within 12 Months After Surgery
Description	MACEs within 12 months after surgery: defined as a non-weighted composite score of: death, stroke, worsening heart failure (+1 NYHA Class), CHF hospitalization, and mitral valve [MV] re-intervention.
Time Frame	Within 12 months

Outcome Measure Data

Analysis Population Description

Twenty patients were enrolled in pilot study and 120 patients were enrolled in latter prospective study. Two of 120 patients died in 30d after surgery，leaving 118 patients to be included in this cohort.

Arm/Group Title	A New Operation (Selected Pilot Study)	A New Operation
Arm/Group Description	Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)	Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
Measure Participants	20	118
death	0 0%	2 1.7%
stroke	0 0%	3 2.5%
worsening heart failure (+1 NYHA Class)	0 0%	1 0.8%
mitral valve [MV] re-intervention	0 0%	1 0.8%
Pacemaker implantation	0 0%	1 0.8%

Adverse Events

Time Frame	Within 12 Months After Surgery
Adverse Event Reporting Description	in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
Arm/Group Title	A New Operation (Selected Pilot Study)		A New Operation
Arm/Group Description	Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.		Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
All Cause Mortality
	A New Operation (Selected Pilot Study)		A New Operation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		4/120 (3.3%)
Serious Adverse Events
	A New Operation (Selected Pilot Study)		A New Operation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		24/120 (20%)
Cardiac disorders
heart failure	0/20 (0%)	0	1/120 (0.8%)	1
permanent pacemaker implantation	0/20 (0%)	0	1/120 (0.8%)	1
infective endocarditis	0/20 (0%)	0	1/120 (0.8%)	1
General disorders
30-day (in-hospital) mortality	0/20 (0%)	0	2/120 (1.7%)	2
multiple organ dysfunction syndrome	0/20 (0%)	0	2/120 (1.7%)	2
Infections and infestations
sepsis	0/20 (0%)	0	1/120 (0.8%)	1
deep sternal infection	0/20 (0%)	0	1/120 (0.8%)	1
Nervous system disorders
stroke or transient ischemic attack(TIA)	0/20 (0%)	0	4/120 (3.3%)	4
Renal and urinary disorders
renal failure	0/20 (0%)	0	4/120 (3.3%)	4
Respiratory, thoracic and mediastinal disorders
pneumonia	1/20 (5%)	1	6/120 (5%)	6
respiratory failure	0/20 (0%)	0	2/120 (1.7%)	2
Surgical and medical procedures
Reoperation	0/20 (0%)	0	1/120 (0.8%)	1
Other (Not Including Serious) Adverse Events
	A New Operation (Selected Pilot Study)		A New Operation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		2/120 (1.7%)
Infections and infestations
superficial wound infection	0/20 (0%)	0	2/120 (1.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.