One Staged Hybrid Approach of Surgical/Catheter Ablation for Persistent Atrial Fibrillation

NCT02968056 | Unknown DMC

• 1 other identifier: XH-16-027
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

There are 10 million atrial fibrillation (AF) patients in China, and the patients are risk of stroke, heart failure and sudden death. Persistent AF is still a refractory disease, and single catheter ablation only has a success rate around 30-50%. Hybrid strategy consisting of thoracoscopic epicardial ablation and transvenous endocardial ablation seems to be an attractive procedure to improve the treatment of persistent AF. However, only a few centers reported their preliminary results, and the conclusions are controversial. The investigator previously reported a minimally invasive surgical ablation from left thoracoscope only and achieved good results. Recently, the investigator successfully explored a hybrid procedure combing this unique surgical technique and transvenous catheter ablation. Here, the investigator present a study to evaluate the efficacy and safety of this novel hybrid procedure. The hypothesis is that a hybrid approach is more efficient than surgical ablation alone in the treatment of persistent AF. 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.

Conditions

Persistent Atrial Fibrillation

Keywords

atrial fibrillation; radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• Sinus rhythm maintenance rate

  Based on ECG results from 3 months and 6 months after the surgery. Any non-sinus rhythm lasting \>30 seconds captured on ECG at any time will be considered failure to maintain sinus rhythm

  At 6 months after the surgery

Secondary Outcomes (8)

• Off any antiarrhythmic drug rate

  6 months after the surgery

• Perioperative complications

  Within 1 month after the surgery

• Major cardiovascular events

  Within 6 months after discharge

• Stroke

  Within 6 months after the surgery

• Left ventricular systolic function

  At 6 months after the surgery

Study Arms (2)

Hybrid group

EXPERIMENTAL

Minimally invasive surgical radiofrequency ablation of atrial fibrillation followed by catheterized radiofrequency ablation within the same procedure

Procedure: Radiofrequency ablation

MIS group

ACTIVE COMPARATOR

Minimally invasive surgical radiofrequency ablation of atrial fibrillation only

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablation PROCEDURE

Radiofrequency energy is used for ablation in both arms of this study (Hybrid group and MIS group)

Hybrid group; MIS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Isolated atrial fibrillation, without structural heart disease.
• Persistent atrial fibrillation (Af last time \> 7 days, including persistent long standing atrial fibrillation)
• 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.
• Patient admitted with intent to treat by either hybrid or surgical ablation
• Consent

You may not qualify if:

• Previous surgical ablation of atrial fibrillation
• Concomitant other cardiac diseases which require surgery at the same procedure, such as heart valve disease, congenital heart disease, coronary disease, dilated cardiomyopathy etc.
• With other forms of severe arrhythmia
• Ejection fraction of left ventricle less than 30%
• Anteroposterior diameter of left atrial over 60mm
• Tumor, active infection, pregnancy.
• Previous surgeries with left thoracotomy, or expected left pleural adhesion, such as history of tuberculosis infection, pleural effusion, pneumothorax etc.
• Hyperthyroidism
• Thrombosis within left atrial appendage
• General conditions too weak to tolerate the surgeries
• Patient's circumstance that precludes completion of follow-up and/or obtaining information from the 1-year follow-up
• Other conditions not appropriate for this study based on the investigators' judgments

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (14)

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  PMID: 22082673 BACKGROUND

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  PMID: 23123991 BACKGROUND

• 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.

  PMID: 22742400 BACKGROUND

• 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.

  PMID: 24016147 BACKGROUND

• 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.

  PMID: 24516803 BACKGROUND

• 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.

  PMID: 23904136 BACKGROUND

• 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.

  PMID: 23122696 BACKGROUND

• 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.

  PMID: 24885377 BACKGROUND

• 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.

  PMID: 25809548 BACKGROUND

• 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.

  PMID: 25809549 BACKGROUND

• 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.

  PMID: 25721819 BACKGROUND

• 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.

  PMID: 26003961 BACKGROUND

• 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.

  PMID: 26725742 BACKGROUND

• 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.

  PMID: 22389422 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Xin Zhou, MD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Ju Mei, MD and PhD

CONTACT

86-21-25078030; ju_mei63@126.com

Jiaquan Zhu, MD and PhD

CONTACT

86-21-25078051; somzjq@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2016
• First Posted: November 18, 2016
• Study Start: December 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

CN (1)