Tailored Treatment of Permanent Atrial Fibrillation (TTOP-AF)
2018年9月17日 更新者：Medtronic Cardiac Rhythm and Heart Failure
Tailored Treatment of Permanent Atrial Fibrillation - TTOP-AF
The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
210
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Arizona
-
Scottsdale、Arizona、美国、85251
- Arizona Arrhythmia Research Center
-
-
California
-
Los Angeles、California、美国、90095
- UCLA Cardiac Arrhythmia Center
-
-
Florida
-
Jacksonville、Florida、美国、32224
- Mayo Clinic Jacksonville
-
-
Georgia
-
Atlanta、Georgia、美国、30309
- Piedmont Hospital
-
Atlanta、Georgia、美国、30308
- Emory Crawford Long Hospital
-
-
Illinois
-
Chicago、Illinois、美国、60637
- University of Chicago
-
-
Indiana
-
Indianapolis、Indiana、美国、46202
- Krannert Institute of Cardiology
-
-
Iowa
-
Davenport、Iowa、美国、52803
- Genesis Medical Center
-
Des Moines、Iowa、美国、50309
- Iowa Heart Center
-
-
Maryland
-
Baltimore、Maryland、美国、21287
- Johns Hopkins Hospital
-
Takoma Park、Maryland、美国、20912
- Washington Adventist Hospital
-
-
Massachusetts
-
Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital
-
Boston、Massachusetts、美国、02114
- Massachusetts General Hospital Cardiac Arrhythmia
-
Burlington、Massachusetts、美国、01805
- Lahey Clinic
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109
- University of Michigan
-
Grand Rapids、Michigan、美国、49503
- Spectrum Health Research Department
-
-
New York
-
Rochester、New York、美国、14642
- University of Rochester
-
-
North Carolina
-
Winston-Salem、North Carolina、美国、27157
- Wake Forest University
-
-
Ohio
-
Columbus、Ohio、美国、43210
- The Ohio State University
-
-
Pennsylvania
-
Erie、Pennsylvania、美国、16502
- Consultants in Cardiovascular Diseases
-
-
Texas
-
Austin、Texas、美国、78756
- Austin Heart
-
Houston、Texas、美国、77030
- Texas Heart Institute at St. Luke's Episcopal
-
-
Virginia
-
Norfolk、Virginia、美国、23507
- Sentara Cardiovascular Research Institute
-
-
-
-
-
Nieuwegein、荷兰
- St. Antonius Ziekenhuis
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
INCLUSION CRITERIA:
- History of symptomatic, continuous atrial fibrillation defined as: Continuous atrial fibrillation lasting greater than 1 year but less than 4 years or nonself-terminating atrial fibrillation, lasting greater than 7 days but no more than 1 year, with at least one failed direct current cardioversion. A failed cardioversion was defined as an unsuccessful cardioversion or one in which normal sinus rhythm was established but not maintained beyond 7 days.
- Atrial fibrillation symptoms included the following: palpitations, fatigue,exertional dyspnea, exercise intolerance
- Age between 18 and 70 years
- Failure of at least one Class I or III rhythm control drug
- Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.
EXCLUSION CRITERIA:
Structural heart disease of clinical significance including:
- Previous cardiac surgery (excluding coronary artery bypass graft and mitral valve repair)
- Symptoms of congestive heart failure including, but not limited to, New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented ejection fraction <40% measured by acceptable cardiac testing
- Left atrial diameter >55 mm
- Moderate to severe mitral or aortic valvular heart disease
- Stable/unstable angina or ongoing myocardial ischemia
- Myocardial infarction (MI) within 3 months of enrollment
- Congenital heart disease (not including atrial septal defect or patent foramen ovale without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
- Prior atrial septal defect of patent foramen ovale closure with a device using a percutaneous approach
- Hypertrophic cardiomyopathy (left ventricular septal wall thickness >1.5 cm)
- Pulmonary hypertension (mean or systolic pulmonary artery pressure >50 mm Hg on Doppler echo)
- Any prior ablation for atrial fibrillation
- Enrollment in any other ongoing arrhythmia study
- Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study
- Active infection or sepsis
- Any history of cerebral vascular disease including stroke or transient ischemic attacks
- Pregnancy or lactation
- Left atrial thrombus at the time of ablation
- Untreatable allergy to contrast media
- Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
- History of blood clotting (bleeding or thrombotic) abnormalities
- Known sensitivities to heparin or warfarin
- Severe chronic obstructive pulmonary disease (defined as forced expiratory volume 1 (FEV1) <1)
- Severe co-morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1
Ablation Management
|
Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium.
Cardioversion could be used to restore sinus rhythm if needed.
|
|
有源比较器：2
Medical Management
|
Arm 2 (Medical Management): Class I or III antiarrhythmic drugs.
Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed.
Direct current cardioversions were also allowed at the discretion of the investigator.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Chronic Effectiveness
大体时间：6 months
|
The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included:
|
6 months
|
|
Acute Safety
大体时间：7 days
|
The primary endpoint for acute safety was a success/failure variable calculated for each subject in Ablation Management at the 7 day post-procedure time point.
Any subject with at least one adverse event adjudicated by the Data Safety Monitoring Board as both serious and either probably or definitely procedure and/or device-related occurring within 7 days of the ablation procedure was considered an acute safety failure, regardless of whether the event occurred following the index or retreatment ablation procedure.
|
7 days
|
|
Chronic Safety
大体时间：6 months
|
The primary endpoint for chronic safety was a success/failure variable calculated for each subject at 6 months.
Any subject that had at least one adverse event that met designated seriousness and relatedness criteria for the particular treatment group as adjudicated by the Data Safety Monitoring Board was considered a chronic safety failure.
Adverse events in Ablation Management that were acute (≤7 days) were not included in the chronic safety primary endpoint.
Given the disparity in the length of time at risk between treatment arms,the Chronic Safety endpoint was not statistically powered.
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acute Efficacy
大体时间：Procedure conclusion
|
A treatment success/failure up to the conclusion of the procedure for each subject in Ablation Management. A subject was considered successfully treated if the following were true:
|
Procedure conclusion
|
|
Improvement of Left Atrial Size at 6 Months Compared to Baseline.
大体时间：6 months
|
Left atrial diameter (LAD), as measured by transthoracic echocardiogram (TTE) looking at the longitudinal long axis at baseline and at the 6 month follow-up visit in both the Ablation and Medical Management arms.
|
6 months
|
|
Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline.
大体时间：6 months
|
Left ventricular ejection fraction (LVEF), as measured by transthoracic echocardiogram at baseline and 6 months in both the Ablation and Medical Management arms.
|
6 months
|
|
Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline.
大体时间：6 months
|
The severity of subject's atrial fibrillation related symptoms on a scale from 1 (no symptoms) to 5 (most severe).
The symptoms included palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and lack of energy during exertion or exercise.
The scores were tabulated at the 1, 3 and 6 month follow-up visits.
Scores could range from 5 to 25, indicating a spectrum of subject status from asymptomatic to severely symptomatic.
|
6 months
|
|
Improved Quality of Life Over 6 Months Compared to Baseline.
大体时间：6 months
|
The SF-36 questionnaire was administered to subjects at baseline, 1, 3 and 6 month visits.
The SF-36 is a multi-purpose, short-form health survey with only 36 questions.
It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based Physical Component Score and Mental Component Score.
The possible range for Physical Component Score and Mental Component Score is 0 to 100.
The higher score, the better quality of life.
|
6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Hindricks G, Piorkowski C, Tanner H, Kobza R, Gerds-Li JH, Carbucicchio C, Kottkamp H. Perception of atrial fibrillation before and after radiofrequency catheter ablation: relevance of asymptomatic arrhythmia recurrence. Circulation. 2005 Jul 19;112(3):307-13. doi: 10.1161/CIRCULATIONAHA.104.518837. Epub 2005 Jul 11.
- Vasamreddy CR, Dalal D, Dong J, Cheng A, Spragg D, Lamiy SZ, Meininger G, Henrikson CA, Marine JE, Berger R, Calkins H. Symptomatic and asymptomatic atrial fibrillation in patients undergoing radiofrequency catheter ablation. J Cardiovasc Electrophysiol. 2006 Feb;17(2):134-9. doi: 10.1111/j.1540-8167.2006.00359.x.
- Marrouche NF, Martin DO, Wazni O, Gillinov AM, Klein A, Bhargava M, Saad E, Bash D, Yamada H, Jaber W, Schweikert R, Tchou P, Abdul-Karim A, Saliba W, Natale A. Phased-array intracardiac echocardiography monitoring during pulmonary vein isolation in patients with atrial fibrillation: impact on outcome and complications. Circulation. 2003 Jun 3;107(21):2710-6. doi: 10.1161/01.CIR.0000070541.83326.15. Epub 2003 May 19.
- Wazni OM, Marrouche NF, Martin DO, Verma A, Bhargava M, Saliba W, Bash D, Schweikert R, Brachmann J, Gunther J, Gutleben K, Pisano E, Potenza D, Fanelli R, Raviele A, Themistoclakis S, Rossillo A, Bonso A, Natale A. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial. JAMA. 2005 Jun 1;293(21):2634-40. doi: 10.1001/jama.293.21.2634.
- Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054.
- Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006 Aug 15;114(7):e257-354. doi: 10.1161/CIRCULATIONAHA.106.177292. No abstract available. Erratum In: Circulation. 2007 Aug 7;116(6):e138.
- Oral H, Pappone C, Chugh A, Good E, Bogun F, Pelosi F Jr, Bates ER, Lehmann MH, Vicedomini G, Augello G, Agricola E, Sala S, Santinelli V, Morady F. Circumferential pulmonary-vein ablation for chronic atrial fibrillation. N Engl J Med. 2006 Mar 2;354(9):934-41. doi: 10.1056/NEJMoa050955.
- Saad EB, Rossillo A, Saad CP, Martin DO, Bhargava M, Erciyes D, Bash D, Williams-Andrews M, Beheiry S, Marrouche NF, Adams J, Pisano E, Fanelli R, Potenza D, Raviele A, Bonso A, Themistoclakis S, Brachmann J, Saliba WI, Schweikert RA, Natale A. Pulmonary vein stenosis after radiofrequency ablation of atrial fibrillation: functional characterization, evolution, and influence of the ablation strategy. Circulation. 2003 Dec 23;108(25):3102-7. doi: 10.1161/01.CIR.0000104569.96907.7F. Epub 2003 Nov 17.
- Pappone C, Rosanio S, Augello G, Gallus G, Vicedomini G, Mazzone P, Gulletta S, Gugliotta F, Pappone A, Santinelli V, Tortoriello V, Sala S, Zangrillo A, Crescenzi G, Benussi S, Alfieri O. Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation: outcomes from a controlled nonrandomized long-term study. J Am Coll Cardiol. 2003 Jul 16;42(2):185-97. doi: 10.1016/s0735-1097(03)00577-1.
- Fuster V, Ryden LE, Asinger RW, Cannom DS, Crijns HJ, Frye RL, Halperin JL, Kay GN, Klein WW, Levy S, McNamara RL, Prystowsky EN, Wann LS, Wyse DG, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Russell RO, Smith SC, Klein WW, Alonso-Garcia A, Blomstrom-Lundqvist C, De Backer G, Flather M, Hradec J, Oto A, Parkhomenko A, Silber S, Torbicki A; American College of Cardiology/American Heart Association/European Society of Cardiology Board. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: executive summary. A Report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation): developed in Collaboration With the North American Society of Pacing and Electrophysiology. J Am Coll Cardiol. 2001 Oct;38(4):1231-66. doi: 10.1016/s0735-1097(01)01587-x. No abstract available.
- Benussi S, Nascimbene S, Calori G, Denti P, Ziskind Z, Kassem S, La Canna G, Pappone C, Alfieri O. Surgical ablation of atrial fibrillation with a novel bipolar radiofrequency device. J Thorac Cardiovasc Surg. 2005 Aug;130(2):491-7. doi: 10.1016/j.jtcvs.2005.01.009.
- Dill T, Neumann T, Ekinci O, Breidenbach C, John A, Erdogan A, Bachmann G, Hamm CW, Pitschner HF. Pulmonary vein diameter reduction after radiofrequency catheter ablation for paroxysmal atrial fibrillation evaluated by contrast-enhanced three-dimensional magnetic resonance imaging. Circulation. 2003 Feb 18;107(6):845-50. doi: 10.1161/01.cir.0000048146.81336.1d.
- Dong J, Vasamreddy CR, Jayam V, Dalal D, Dickfeld T, Eldadah Z, Meininger G, Halperin HR, Berger R, Bluemke DA, Calkins H. Incidence and predictors of pulmonary vein stenosis following catheter ablation of atrial fibrillation using the anatomic pulmonary vein ablation approach: results from paired magnetic resonance imaging. J Cardiovasc Electrophysiol. 2005 Aug;16(8):845-52. doi: 10.1111/j.1540-8167.2005.40680.x.
- Food and Drug Administration Guidance for Industry and FDA Staff: Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation, January 9, 2004.
- Abreu Filho CA, Lisboa LA, Dallan LA, Spina GS, Grinberg M, Scanavacca M, Sosa EA, Ramires JA, Oliveira SA. Effectiveness of the maze procedure using cooled-tip radiofrequency ablation in patients with permanent atrial fibrillation and rheumatic mitral valve disease. Circulation. 2005 Aug 30;112(9 Suppl):I20-5. doi: 10.1161/CIRCULATIONAHA.104.526301.
- Fisher JD, Spinelli MA, Mookherjee D, Krumerman AK, Palma EC. Atrial fibrillation ablation: reaching the mainstream. Pacing Clin Electrophysiol. 2006 May;29(5):523-37. doi: 10.1111/j.1540-8159.2006.00388.x.
- Gajewski J, Singer RB. Mortality in an insured population with atrial fibrillation. JAMA. 1981 Apr 17;245(15):1540-4.
- de Lima GG, Kalil RA, Leiria TL, Hatem DM, Kruse CL, Abrahao R, Sant'anna JR, Prates PR, Nesralla IA. Randomized study of surgery for patients with permanent atrial fibrillation as a result of mitral valve disease. Ann Thorac Surg. 2004 Jun;77(6):2089-94; discussion 2094-5. doi: 10.1016/j.athoracsur.2003.11.018.
- Hornero F, Rodriguez I, Bueno M, Buendia J, Dalmau MJ, Canovas S, Gil O, Garcia R, Montero JA. Surgical ablation of permanent atrial fibrillation by means of maze radiofrequency: mid-term results. J Card Surg. 2004 Sep-Oct;19(5):383-8. doi: 10.1111/j.0886-0440.2004.04077.x.
- Kerr CR, Humphries KH, Talajic M, Klein GJ, Connolly SJ, Green M, Boone J, Sheldon R, Dorian P, Newman D. Progression to chronic atrial fibrillation after the initial diagnosis of paroxysmal atrial fibrillation: results from the Canadian Registry of Atrial Fibrillation. Am Heart J. 2005 Mar;149(3):489-96. doi: 10.1016/j.ahj.2004.09.053.
- Packer DL, Asirvatham S, Munger TM. Progress in nonpharmacologic therapy of atrial fibrillation. J Cardiovasc Electrophysiol. 2003 Dec;14(12 Suppl):S296-309. doi: 10.1046/j.1540-8167.2003.90403.x. No abstract available.
- PMA P020025 - Summary of Safety and Effectiveness Data: Boston Scientific Corporation Blazer II XP™ Cardiac Ablation Catheter, August 25, 2003.
- PMA P030031 - Summary of Safety and Effectiveness Data: Biosense Webster Navistar™/Celsius™ThermoCool® Diagnostic/Ablation Deflectable Tip Catheters, November 5, 2004.
- PMA P040042 - Summary of Safety and Effectiveness Data: Irvine Biomedical, Inc. IBI Therapy™ Dual 8™ Ablation Catheter, November 18, 2005.
- Saad EB, Cole CR, Marrouche NF, Dresing TJ, Perez-Lugones A, Saliba WI, Schweikert RA, Klein A, Rodriguez L, Grimm R, Tchou P, Natale A. Use of intracardiac echocardiography for prediction of chronic pulmonary vein stenosis after ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2002 Oct;13(10):986-9. doi: 10.1046/j.1540-8167.2002.00986.x.
- Scardi S, Mazzone C, Pandullo C, Goldstein D, Poletti A, Humar F. Lone atrial fibrillation: prognostic differences between paroxysmal and chronic forms after 10 years of follow-up. Am Heart J. 1999 Apr;137(4 Pt 1):686-91. doi: 10.1016/s0002-8703(99)70224-3.
- Vasamreddy CR, Dalal D, Eldadah Z, Dickfeld T, Jayam VK, Henrickson C, Meininger G, Dong J, Lickfett L, Berger R, Calkins H. Safety and efficacy of circumferential pulmonary vein catheter ablation of atrial fibrillation. Heart Rhythm. 2005 Jan;2(1):42-8. doi: 10.1016/j.hrthm.2004.10.027.
- Chen YJ, Chen SA, Tai CT, Wen ZC, Feng AN, Ding YA, Chang MS. Role of atrial electrophysiology and autonomic nervous system in patients with supraventricular tachycardia and paroxysmal atrial fibrillation. J Am Coll Cardiol. 1998 Sep;32(3):732-8. doi: 10.1016/s0735-1097(98)00305-2.
- Haissaguerre M, Sanders P, Hocini M, Hsu LF, Shah DC, Scavee C, Takahashi Y, Rotter M, Pasquie JL, Garrigue S, Clementy J, Jais P. Changes in atrial fibrillation cycle length and inducibility during catheter ablation and their relation to outcome. Circulation. 2004 Jun 22;109(24):3007-13. doi: 10.1161/01.CIR.0000130645.95357.97. Epub 2004 Jun 7.
- Sanders P, Nalliah CJ, Dubois R, Takahashi Y, Hocini M, Rotter M, Rostock T, Sacher F, Hsu LF, Jonsson A, O'Neill MD, Jais P, Haissaguerre M. Frequency mapping of the pulmonary veins in paroxysmal versus permanent atrial fibrillation. J Cardiovasc Electrophysiol. 2006 Sep;17(9):965-72. doi: 10.1111/j.1540-8167.2006.00546.x.
- Jais P, Hocini M, Sanders P, Hsu LF, Takahashi Y, Rotter M, Rostock T, Sacher F, Clementy J, Haissaguerre M. Long-term evaluation of atrial fibrillation ablation guided by noninducibility. Heart Rhythm. 2006 Feb;3(2):140-5. doi: 10.1016/j.hrthm.2005.11.012.
- Earley MJ, Abrams DJ, Staniforth AD, Sporton SC, Schilling RJ. Catheter ablation of permanent atrial fibrillation: medium term results. Heart. 2006 Feb;92(2):233-8. doi: 10.1136/hrt.2005.066969. Epub 2005 Aug 23.
- Nilsson B, Chen X, Pehrson S, Kober L, Hilden J, Svendsen JH. Recurrence of pulmonary vein conduction and atrial fibrillation after pulmonary vein isolation for atrial fibrillation: a randomized trial of the ostial versus the extraostial ablation strategy. Am Heart J. 2006 Sep;152(3):537.e1-8. doi: 10.1016/j.ahj.2006.05.029.
- Rotter M, Takahashi Y, Sanders P, Haissaguerre M, Jais P, Hsu LF, Sacher F, Pasquie JL, Clementy J, Hocini M. Reduction of fluoroscopy exposure and procedure duration during ablation of atrial fibrillation using a novel anatomical navigation system. Eur Heart J. 2005 Jul;26(14):1415-21. doi: 10.1093/eurheartj/ehi172. Epub 2005 Mar 1.
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年5月1日
初级完成 (实际的)
2010年11月1日
研究完成 (实际的)
2010年11月1日
研究注册日期
首次提交
2007年8月8日
首先提交符合 QC 标准的
2007年8月8日
首次发布 (估计)
2007年8月10日
研究记录更新
最后更新发布 (实际的)
2018年10月16日
上次提交的符合 QC 标准的更新
2018年9月17日
最后验证
2018年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.