Concomitant Focal Epicardial Cryoablation During Mei Mini Maze Procedure in Treatment of Lone Atrial Fibrillation

NCT04522024 | Unknown

• 1 other identifier: XH-20-019
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Atrial fibrillation (AF) increases risks of stroke, heart failure and sudden death. Single catheter ablation only has a low success rate due to inadequate transmurality and continuity of the lesion lines. Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side (Mei Mini Maze procedure, 3M procedure) was applied in our institution in the last 10 years, and gained reasonable results. A more attractive hybrid strategy of epicardial and endocardial ablation was tested to improve the treatment of persistent AF in the investigator's hospital (NCT02968056). Preliminary data from this trial found that insufficient ablation around right upper pulmonary vein area was the key point leading to failure or recurrence. In order to overcome this weakness of the current Mei Mini Maze procedure, concomitant focal epicardial cryoablation performed during the operation may reinforce the lesion lines. The hypothesis of the present study is that additional epicardial cryoablation will improve the success rate compared to Mei Mini Maze procedure alone in the treatment of AF. This study is a prospective randomized controlled trial within a single institution. Lone AF patients admitted to the cardiovascular surgery department of Shanghai Xinhua Hospital will be screened for enrollment of this study. The study will recruit 150 patients in total. The patients will be randomized allocated into Mei Mini Maze procedure group (3M group) and Concomitant epicardial cryoablation group (3M + Cryoablation group). The 3M group patients only have surgical ablation surgery from left thoracoscope as previously reported, while the 3M + Cryoablation group patients will have additional focal epicardial cryoablation around right upper pulmonary vein area after the Mei Mini Maze procedure is done. The ratio of 3M to 3M + cryoablation group is 1:1, so that each group contains 75 patients. The perioperative data is collected, and the patients will be followed for 6 months. The primary outcome is the maintenance 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 of this study is to evaluate the efficacy and safety of this novel combined procedure of epicardial radiofrequency and cryoablation.

Conditions

Lone Atrial Fibrillation

Keywords

epicardial cryoablation; epicardial radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• Sinus rhythm maintenance rate

  Based on ECG and Holter results 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 post operation

Secondary Outcomes (8)

• Off any antiarrhythmic drug rate

  At 6 months post operation

• Perioperative complications

  Within 1 month after the surgery

• Major cardiovascular events

  Within 6 months post operation

• Rate of new onset stroke

  Within 6 months post operation

• Left ventricular systolic function

  At 6 months post operation

Study Arms (2)

Mei Mini Maze

ACTIVE COMPARATOR

Mei Mini Maze procedure (Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side)

Procedure: Mei Mini Maze procedure

Mei Mini Maze plus epicardial cryoablation

EXPERIMENTAL

Epicardial focal cryoablation during Mei Mini Maze procedure

Procedure: Epicardial focal cryoablation

Interventions

Epicardial focal cryoablation PROCEDURE

Epicardial focal cryoablation on the left atrium around right upper pulmonary vein area

Mei Mini Maze plus epicardial cryoablation

Mei Mini Maze procedure PROCEDURE

Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side

Mei Mini Maze

Eligibility Criteria

• Age: 18 Years - 85 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.
• Failed medical treatment
• Patient admitted with intent to be treated by surgical ablation

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 6 months 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

Related Publications (8)

• 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

• 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.

  PMID: 22082673 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

• van der Heijden CAJ, Vroomen M, Luermans JG, Vos R, Crijns HJGM, Gelsomino S, La Meir M, Pison L, Maesen B. Hybrid versus catheter ablation in patients with persistent and longstanding persistent atrial fibrillation: a systematic review and meta-analysisdagger. Eur J Cardiothorac Surg. 2019 Sep 1;56(3):433-443. doi: 10.1093/ejcts/ezy475.

  PMID: 30698685 BACKGROUND

• Cox JL, Churyla A, Malaisrie SC, Pham DT, Kruse J, Kislitsina ON, McCarthy PM. A Hybrid Maze Procedure for Long-Standing Persistent Atrial Fibrillation. Ann Thorac Surg. 2019 Feb;107(2):610-618. doi: 10.1016/j.athoracsur.2018.06.064. Epub 2018 Aug 14.

  PMID: 30118714 BACKGROUND

• Milla F, Skubas N, Briggs WM, Girardi LN, Lee LY, Ko W, Tortolani AJ, Krieger KH, Isom OW, Mack CA. Epicardial beating heart cryoablation using a novel argon-based cryoclamp and linear probe. J Thorac Cardiovasc Surg. 2006 Feb;131(2):403-11. doi: 10.1016/j.jtcvs.2005.10.048. Epub 2006 Jan 18.

  PMID: 16434271 BACKGROUND

• Wang W, Jiang Z, Lu R, Liu H, Ma N, Cai J, Tang M, Mei J. Effects of Renal Denervation via Renal Artery Adventitial Cryoablation on Atrial Fibrillation and Cardiac Neural Remodeling. Cardiol Res Pract. 2018 Dec 11;2018:2603025. doi: 10.1155/2018/2603025. eCollection 2018.

  PMID: 30647968 BACKGROUND

• Blomstrom-Lundqvist C, Johansson B, Berglin E, Nilsson L, Jensen SM, Thelin S, Holmgren A, Edvardsson N, Kallner G, Blomstrom P. A randomized double-blind study of epicardial left atrial cryoablation for permanent atrial fibrillation in patients undergoing mitral valve surgery: the SWEDish Multicentre Atrial Fibrillation study (SWEDMAF). Eur Heart J. 2007 Dec;28(23):2902-8. doi: 10.1093/eurheartj/ehm378. Epub 2007 Nov 5.

  PMID: 17984136 BACKGROUND

Study Officials

• Yaosheng Wang, MD & Ph.D

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Jiaquan Zhu, MD & Ph.D

CONTACT

86-13651951806; dr_zhujq@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: October 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2023
• Last Updated: August 21, 2020

Record last verified: 2020-08