One Staged Hybrid Approach of Surgical/Catheter Ablation for Persistent Atrial Fibrillation
NCT ID: NCT02968056
Last Updated: 2018-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2016-12-31
2019-10-31
Brief Summary
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This study is a non-randomized controlled study within a single institution. Isolated persistent AF patients admitted to the cardiovascular surgery department of Shanghai Xinhua Hospital will be screened for enrollment of this study. The study will recruit 180 patients in total. Based on their own willingness, the patients will be divided into hybrid group and minimally invasive (MIS) group. The MIS group patients only have surgical ablation surgery from left thoracoscope as the investigator reported before, while the hybrid group patients will have additional transvenous catheter ablation after the surgical ablation is done during the same operation. The ratio of hybrid to MIS group is expected to be 1:1, so that each group contains 90 patients. The perioperative data is collected, and the patients will be followed for 6 months. The primary outcome is the rate of sinus rhythm at 6 months post operation. The secondary outcomes include off antiarrhythmic drug rate, perioperative complications, major cardiovascular events, stroke, left ventricular systolic function, medical expense, serum brain natriuretic peptide level and quality of life. The aim is to evaluate the efficacy and safety of this novel hybrid procedure, therefore to provide more evidence of the hybrid strategy in the treatment of persistent AF.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hybrid group
Minimally invasive surgical radiofrequency ablation of atrial fibrillation followed by catheterized radiofrequency ablation within the same procedure
Radiofrequency ablation
Radiofrequency energy is used for ablation in both arms of this study (Hybrid group and MIS group)
MIS group
Minimally invasive surgical radiofrequency ablation of atrial fibrillation only
Radiofrequency ablation
Radiofrequency energy is used for ablation in both arms of this study (Hybrid group and MIS group)
Interventions
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Radiofrequency ablation
Radiofrequency energy is used for ablation in both arms of this study (Hybrid group and MIS group)
Eligibility Criteria
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Inclusion Criteria
2. Persistent atrial fibrillation (Af last time \> 7 days, including persistent long standing atrial fibrillation)
3. Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication; symptomatic patients are those who have been aware of their AF at any time within the last 5 years before enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of these.
4. Patient admitted with intent to treat by either hybrid or surgical ablation
5. Consent
Exclusion Criteria
2. Concomitant other cardiac diseases which require surgery at the same procedure, such as heart valve disease, congenital heart disease, coronary disease, dilated cardiomyopathy etc.
3. With other forms of severe arrhythmia
4. Ejection fraction of left ventricle less than 30%
5. Anteroposterior diameter of left atrial over 60mm
6. Tumor, active infection, pregnancy.
7. Previous surgeries with left thoracotomy, or expected left pleural adhesion, such as history of tuberculosis infection, pleural effusion, pneumothorax etc.
8. Hyperthyroidism
9. Thrombosis within left atrial appendage
10. General conditions too weak to tolerate the surgeries
11. Patient's circumstance that precludes completion of follow-up and/or obtaining information from the 1-year follow-up
12. Other conditions not appropriate for this study based on the investigators' judgments
18 Years
ALL
No
Sponsors
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Ju Mei
Professor
Principal Investigators
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Xin Zhou, MD
Role: STUDY_DIRECTOR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Ju Mei, MD and PhD
Role: primary
References
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Boersma LV, Castella M, van Boven W, Berruezo A, Yilmaz A, Nadal M, Sandoval E, Calvo N, Brugada J, Kelder J, Wijffels M, Mont L. Atrial fibrillation catheter ablation versus surgical ablation treatment (FAST): a 2-center randomized clinical trial. Circulation. 2012 Jan 3;125(1):23-30. doi: 10.1161/CIRCULATIONAHA.111.074047. Epub 2011 Nov 14.
Muneretto C, Bisleri G, Bontempi L, Cheema FH, Curnis A. Successful treatment of lone persistent atrial fibrillation by means of a hybrid thoracoscopic-transcatheter approach. Innovations (Phila). 2012 Jul-Aug;7(4):254-8. doi: 10.1097/IMI.0b013e31826f0462.
Pison L, La Meir M, van Opstal J, Blaauw Y, Maessen J, Crijns HJ. Hybrid thoracoscopic surgical and transvenous catheter ablation of atrial fibrillation. J Am Coll Cardiol. 2012 Jul 3;60(1):54-61. doi: 10.1016/j.jacc.2011.12.055.
Pokushalov E, Romanov A, Elesin D, Bogachev-Prokophiev A, Losik D, Bairamova S, Karaskov A, Steinberg JS. Catheter versus surgical ablation of atrial fibrillation after a failed initial pulmonary vein isolation procedure: a randomized controlled trial. J Cardiovasc Electrophysiol. 2013 Dec;24(12):1338-43. doi: 10.1111/jce.12245. Epub 2013 Sep 9.
Cox JL. A brief overview of surgery for atrial fibrillation. Ann Cardiothorac Surg. 2014 Jan;3(1):80-8. doi: 10.3978/j.issn.2225-319X.2014.01.05.
Gelsomino S, Van Breugel HN, Pison L, Parise O, Crijns HJ, Wellens F, Maessen JG, La Meir M. Hybrid thoracoscopic and transvenous catheter ablation of atrial fibrillation. Eur J Cardiothorac Surg. 2014 Mar;45(3):401-7. doi: 10.1093/ejcts/ezt385. Epub 2013 Jul 31.
Mei J, Ma N, Ding F, Chen Y, Jiang Z, Hu F, Xiao H. Complete thoracoscopic ablation of the left atrium via the left chest for treatment of lone atrial fibrillation. J Thorac Cardiovasc Surg. 2014 Jan;147(1):242-6. doi: 10.1016/j.jtcvs.2012.10.005. Epub 2012 Nov 2.
Pragliola C, Mastroroberto P, Gaudino M, Chello M, Covino E. Staged transthoracic approach to persistent atrial fibrillation (TOP-AF): study protocol for a randomized trial. Trials. 2014 May 26;15:190. doi: 10.1186/1745-6215-15-190.
Bulava A, Mokracek A, Hanis J, Kurfirst V, Eisenberger M, Pesl L. Sequential hybrid procedure for persistent atrial fibrillation. J Am Heart Assoc. 2015 Mar 25;4(3):e001754. doi: 10.1161/JAHA.114.001754.
Wang PJ. Hybrid epicardial and endocardial ablation of atrial fibrillation: is ablation on two sides of the atrial wall better than one? J Am Heart Assoc. 2015 Mar 25;4(3):e001893. doi: 10.1161/JAHA.115.001893. No abstract available.
Beukema RJ, Adiyaman A, Smit JJ, Delnoy PP, Ramdat Misier AR, Elvan A. Catheter ablation of symptomatic postoperative atrial arrhythmias after epicardial surgical disconnection of the pulmonary veins and left atrial appendage ligation in patients with atrial fibrillation. Eur J Cardiothorac Surg. 2016 Jan;49(1):265-71. doi: 10.1093/ejcts/ezv047. Epub 2015 Feb 26.
Phan K, Phan S, Thiagalingam A, Medi C, Yan TD. Thoracoscopic surgical ablation versus catheter ablation for atrial fibrillation. Eur J Cardiothorac Surg. 2016 Apr;49(4):1044-51. doi: 10.1093/ejcts/ezv180. Epub 2015 May 23.
Richardson TD, Shoemaker MB, Whalen SP, Hoff SJ, Ellis CR. Staged versus Simultaneous Thoracoscopic Hybrid Ablation for Persistent Atrial Fibrillation Does Not Affect Time to Recurrence of Atrial Arrhythmia. J Cardiovasc Electrophysiol. 2016 Apr;27(4):428-34. doi: 10.1111/jce.12906. Epub 2016 Jan 29.
Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. Europace. 2012 Apr;14(4):528-606. doi: 10.1093/europace/eus027. Epub 2012 Mar 1. No abstract available.
Other Identifiers
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XH-16-027
Identifier Type: -
Identifier Source: org_study_id
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