Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A new operation | Experimental | Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure |
|
| A new operation (Selected pilot study) | Other | Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of Participants Free From AF | 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 | 3, 6, and 12 months after the operation |
| Intraoperative Cardiopulmonary Bypass Duration | 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. | 1 hour after operation |
| The Adverse Events 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. | Within 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Atrial Anteroposterior Diameter | echocardiographic change in left atrial anteroposterior diameter | 6 months and 12 months post-surgery |
| Change in Left Atrial Transversal Diameter |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Liangwan Chen, M.D | Union Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiovascular Surgery,Union Hospital | Fuzhou | Fujian | 350001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27042964 | Background | Kuck KH, Brugada J, Furnkranz 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. | |
| 25946280 |
Not provided
Not provided
plan to share study protocol, SAP and ICF with other researchers.
Data will become available after the study ends.
cardiovascular researchers
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | A New Operation (Selected Pilot Study) | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
echocardiographic change in left atrial transversal diameter
| 6 months and 12 months post-surgery |
| Change in Left Atrial Superoinferior Diameter | echocardiographic change in left atrial superoinferior diameter | 6 months and 12 months post-surgery |
| The Number of Participants Who Will be Detected the Peak Late Trans-mitral Flow Velocity (A Wave) Reappearance | 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. | 6 months and 12 months post-surgery |
| MACEs Within 12 Months After Surgery | 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. | Within 12 months |
| 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. |
| 23356418 | Background | 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. |
| 27521177 | Background | 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. doi: 10.1093/icvts/ivw256. Epub 2016 Aug 11. |
| 26220695 | Background | 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. doi: 10.1055/s-0035-1554941. Epub 2015 Jul 28. |
| 20370795 | Background | 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. |
| 17008109 | Background | 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. doi: 10.1016/j.ejcts.2006.08.016. Epub 2006 Sep 26. |
| 12411621 | Background | 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. doi: 10.1258/jrsm.95.11.552. No abstract available. |
| 37352525 | Derived | Chen L, Li Q, Chen J, Qiu Z, Xiao J, Tang M, Wu Q, Shen Y, Dai X, Fang G, Lu H. A new procedure for elimination of atrial fibrillation associated with mitral valve disease: a proof-of-concept study. Int J Surg. 2023 Oct 1;109(10):2914-2925. doi: 10.1097/JS9.0000000000000566. |
| FG001 | A New Operation | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | A New Operation (Selected Pilot Study) | 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. |
| BG001 | A New Operation | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Hypertension | Count of Participants | Participants |
| ||||||||||||||||||
| Prior stroke | Count of Participants | Participants |
| ||||||||||||||||||
| Diabetes | Count of Participants | Participants |
| ||||||||||||||||||
| Smoking History | Count of Participants | Participants |
| ||||||||||||||||||
| NYHA Class III or Class IV | New York Heart Association (NYHA) Functional Classification is used to classify patients' heart failure according to the severity of their symptoms. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. Class III and Class IV indicate worse heart function than Class I or Class II, and increase the risk of death for cardiac surgery. | Count of Participants | Participants |
| |||||||||||||||||
| Long-standing persistent AF | Count of Participants | Participants |
| ||||||||||||||||||
| Atrial fibrillation duration | Mean | Standard Deviation | months |
| |||||||||||||||||
| EuroScore | European system for cardiac operative risk evaluation (EuroSCORE) is a scoring system for the prediction of early mortality in cardiac surgical patients. It is the sum of several scored patients-related fators, such as, age, sex, comorbidities and operation information, and so on. Usually, the low risk group is defined as EuroSCORE 1-2 with 0.8% deaths risk, 3% for medium risk group (EuroSCORE 3-5), 11.2% for high risk group (EuroSCORE 6 plus). The range of EuroSCORE in this study is from 0 to 22. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Preoperative amiodarone intake | Count of Participants | Participants |
| ||||||||||||||||||
| Preoperative Digoxin intake | Count of Participants | Participants |
| ||||||||||||||||||
| Preoperative beta-blocker intake | Count of Participants | Participants |
| ||||||||||||||||||
| Preoperative NT-proBNP level | Mean | Standard Deviation | pg/ml |
| |||||||||||||||||
| Preoperative creatine level | Mean | Standard Deviation | μmol/l |
| |||||||||||||||||
| left ventricular diastolic diameter | Mean | Standard Deviation | milimeters |
| |||||||||||||||||
| left ventricular systolic diameter | Mean | Standard Deviation | milimeters |
| |||||||||||||||||
| left ventricular ejection fraction | Mean | Standard Deviation | % |
| |||||||||||||||||
| left atrial anteroposterior diameter | Mean | Standard Deviation | milimeters |
| |||||||||||||||||
| left atrial transversal diameter | Mean | Standard Deviation | milimeters |
| |||||||||||||||||
| left atrial superoinferior diameter | Mean | Standard Deviation | milimeters |
| |||||||||||||||||
| Mitral Lesion | Count of Participants | Participants |
| ||||||||||||||||||
| Aortic Lesion | Count of Participants | Participants |
| ||||||||||||||||||
| Tricuspid Lesion | Count of Participants | Participants |
| ||||||||||||||||||
| Coronary Heart Disease | Count of Participants | Participants |
| ||||||||||||||||||
| mitral valve procedure | Count of Participants | Participants |
| ||||||||||||||||||
| aortic valve replacement | Count of Participants | Participants |
| ||||||||||||||||||
| Tricuspid valve repair | Count of Participants | Participants |
| ||||||||||||||||||
| Concomitant CABG | Count of Participants | Participants |
| ||||||||||||||||||
| Total surgery time | Mean | Standard Deviation | minutes |
| |||||||||||||||||
| aortic cross-clamp duration | Mean | Standard Deviation | minutes |
| |||||||||||||||||
| Total cardiopulmonary bypass time | Mean | Standard Deviation | minutes |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Numbers of Participants Free From AF | 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 | Twenty patients were enrolled in pilot study and 120 patients were enrolled in latter prospective study. | Posted | Count of Participants | Participants | 3, 6, and 12 months after the operation |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Intraoperative Cardiopulmonary Bypass Duration | 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. | Posted | Mean | Standard Deviation | minutes | 1 hour after operation |
| ||||||||||||||||||||||||||||||||||||||
| Primary | The Adverse Events 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. | Posted | Count of Participants | Participants | Within 30 days after surgery |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Left Atrial Anteroposterior Diameter | echocardiographic change in left atrial anteroposterior diameter | 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. | Posted | Mean | Standard Deviation | milimeters | 6 months and 12 months post-surgery |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Left Atrial Transversal Diameter | echocardiographic change in left atrial transversal diameter | 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. | Posted | Mean | Standard Deviation | milimeters | 6 months and 12 months post-surgery |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Left Atrial Superoinferior Diameter | echocardiographic change in left atrial superoinferior diameter | 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. | Posted | Mean | Standard Deviation | milimeters | 6 months and 12 months post-surgery |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Participants Who Will be Detected the Peak Late Trans-mitral Flow Velocity (A Wave) Reappearance | 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. | 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. | Posted | Count of Participants | Participants | 6 months and 12 months post-surgery |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | MACEs Within 12 Months After Surgery | 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. | 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. | Posted | Count of Participants | Participants | Within 12 months |
|
|
Within 12 Months After Surgery
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A New Operation (Selected Pilot Study) | 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. | 0 | 20 | 1 | 20 | 0 | 20 |
| EG001 | A New Operation | 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. | 4 | 120 | 24 | 120 | 2 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 30-day (in-hospital) mortality | General disorders | Non-systematic Assessment |
| ||
| stroke or transient ischemic attack(TIA) | Nervous system disorders | Non-systematic Assessment | All stroke or transient ischemic attack(TIA) events within 12 months after surgery |
| |
| heart failure | Cardiac disorders | Non-systematic Assessment | All heart failure events within 12 months after surgery |
| |
| permanent pacemaker implantation | Cardiac disorders | Non-systematic Assessment | All permanent pacemaker implantation events within 12 months after surgery |
| |
| renal failure | Renal and urinary disorders | Non-systematic Assessment | All renal failure events within 12 months after surgery |
| |
| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | All pneumonia within 12 months after surgery |
| |
| sepsis | Infections and infestations | Non-systematic Assessment | All sepsis events within 12 months after surgery |
| |
| respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | All respiratory failure events within 12 months after surgery |
| |
| multiple organ dysfunction syndrome | General disorders | Non-systematic Assessment | All multiple organ dysfunction syndrome events within 12 months after surgery |
| |
| Reoperation | Surgical and medical procedures | Non-systematic Assessment | All reoperation events within 12 months after surgery |
| |
| deep sternal infection | Infections and infestations | Non-systematic Assessment | All deep sternal infection events within 12 months after surgery |
| |
| infective endocarditis | Cardiac disorders | Non-systematic Assessment | All infective endocarditis events within 12 months after surgery |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| superficial wound infection | Infections and infestations | Non-systematic Assessment |
|
[Not Specified]
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Liangwan Chen | Fujian Medical University Union Hospital | 861335825333 | chenliangwan@tom.com |
| Sep 21, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form for phase1 | Sep 1, 2017 | Sep 21, 2021 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form for phase2 | Aug 1, 2018 | Sep 21, 2021 | ICF_002.pdf |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| mitral valve repair |
|
| 6 months after the operation |
|
| 12 months after the operation |
|
| A New Operation |
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. |
|
|
| OG001 | A New Operation | 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. |
|
|
| A New Operation |
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. |
|
|
|
|
|
|
|