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

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04522024
• Collaborator: (none)
• Enrollment: 150
• Arms: 2
• Anticipated Duration (Months): 35.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lone Atrial Fibrillation	Procedure: Epicardial focal cryoablation; Procedure: Mei Mini Maze procedure	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Concomitant Focal Epicardial Cryoablation During Mei Mini Maze Procedure in Treatment of Lone Atrial Fibrillation: A Randomized Controlled Trial
• Anticipated Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mei Mini Maze Mei Mini Maze procedure (Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side)	Procedure: Mei Mini Maze procedure; Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side
Experimental: Mei Mini Maze plus epicardial cryoablation Epicardial focal cryoablation during Mei Mini Maze procedure	Procedure: Epicardial focal cryoablation; Epicardial focal cryoablation on the left atrium around right upper pulmonary vein area

Outcome Measures

Primary Outcome Measures

1. Sinus rhythm maintenance rate [At 6 months post operation]

   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

Secondary Outcome Measures

1. Off any antiarrhythmic drug rate [At 6 months post operation]

   Off any antiarrhythmic drug rate

2. Perioperative complications [Within 1 month after the surgery]

   Emergent thoracotomy or exploration for bleeding, renal dysfunction requiring new dialysis treatment, respiratory dysfunction requiring prolonged mechanical ventilation with tracheotomy, new pacemaker implantation, and perioperative death

3. Major cardiovascular events [Within 6 months post operation]

   Death, Nonfatal myocardial infarction, re-admission because of heart disease

4. Rate of new onset stroke [Within 6 months post operation]

   New onset of stroke after the surgery, identified by CT or MRI.

5. Left ventricular systolic function [At 6 months post operation]

   Evaluated by ejection fraction from echocardiogram

6. Costs of treatment [From surgery to 6 months after the surgery]

   There are 3 parts. 1. Cost during the first hospitalization; 2. Cost of all the health care from first discharge to 6 months after the surgery, including seeing clinics, medication, re-hospitalization related to atrial fibrillation/surgical complications/new onset of stroke/other atrial fibrillation related complications. 3. Total cost: the combination of the abovementioned two parts.

7. Serum NT-proBNP level [At 6 months post operation]

   The level of serum NT-proBNP

8. Quality of life evaluated by short form 36 questionnaire [At 6 months post operation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Isolated atrial fibrillation, without structural heart disease.

2. Failed medical treatment

3. Patient admitted with intent to be treated by surgical ablation

Exclusion Criteria:

1. Previous surgical ablation of atrial fibrillation

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 6 months follow-up

12. Other conditions not appropriate for this study based on the investigators' judgments

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

• Study Director: Yaosheng Wang, MD & Ph.D, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

• Blomström-Lundqvist C, Johansson B, Berglin E, Nilsson L, Jensen SM, Thelin S, Holmgren A, Edvardsson N, Källner G, Blomström 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. Epub 2007 Nov 5.
• 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.
• 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. Review.
• 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.
• 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. Epub 2006 Jan 18.
• 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. Review.
• 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-analysis†. Eur J Cardiothorac Surg. 2019 Sep 1;56(3):433-443. doi: 10.1093/ejcts/ezy475.
• 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.

• Responsible Party: Jiaquan Zhu, Principal Investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT04522024
• Other Study ID Numbers: XH-20-019
• First Posted: Aug 21, 2020
• Last Update Posted: Aug 21, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jiaquan Zhu, Principal Investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: epicardial cryoablation; epicardial radiofrequency ablation
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Aug 21, 2020