Concomitant Focal Epicardial Cryoablation During Mei Mini Maze Procedure in Treatment of Lone Atrial Fibrillation
Primary Purpose
Lone Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Epicardial focal cryoablation
Mei Mini Maze procedure
Sponsored by
About this trial
This is an interventional treatment trial for Lone Atrial Fibrillation focused on measuring epicardial cryoablation, epicardial radiofrequency ablation
Eligibility Criteria
Inclusion Criteria:
- Isolated atrial fibrillation, without structural heart disease.
- Failed medical treatment
- Patient admitted with intent to be treated by surgical ablation
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Mei Mini Maze
Mei Mini Maze plus epicardial cryoablation
Arm Description
Mei Mini Maze procedure (Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side)
Epicardial focal cryoablation during Mei Mini Maze procedure
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Off any antiarrhythmic drug rate
Off any antiarrhythmic drug rate
Perioperative complications
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
Major cardiovascular events
Death, Nonfatal myocardial infarction, re-admission because of heart disease
Rate of new onset stroke
New onset of stroke after the surgery, identified by CT or MRI.
Left ventricular systolic function
Evaluated by ejection fraction from echocardiogram
Costs of treatment
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.
Serum NT-proBNP level
The level of serum NT-proBNP
Quality of life evaluated by short form 36 questionnaire
Full Information
NCT ID
NCT04522024
First Posted
August 18, 2020
Last Updated
August 20, 2020
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04522024
Brief Title
Concomitant Focal Epicardial Cryoablation During Mei Mini Maze Procedure in Treatment of Lone Atrial Fibrillation
Official Title
Concomitant Focal Epicardial Cryoablation During Mei Mini Maze Procedure in Treatment of Lone Atrial Fibrillation: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lone Atrial Fibrillation
Keywords
epicardial cryoablation, epicardial radiofrequency ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mei Mini Maze
Arm Type
Active Comparator
Arm Description
Mei Mini Maze procedure (Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side)
Arm Title
Mei Mini Maze plus epicardial cryoablation
Arm Type
Experimental
Arm Description
Epicardial focal cryoablation during Mei Mini Maze procedure
Intervention Type
Procedure
Intervention Name(s)
Epicardial focal cryoablation
Intervention Description
Epicardial focal cryoablation on the left atrium around right upper pulmonary vein area
Intervention Type
Procedure
Intervention Name(s)
Mei Mini Maze procedure
Intervention Description
Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side
Primary Outcome Measure Information:
Title
Sinus rhythm maintenance rate
Description
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
Time Frame
At 6 months post operation
Secondary Outcome Measure Information:
Title
Off any antiarrhythmic drug rate
Description
Off any antiarrhythmic drug rate
Time Frame
At 6 months post operation
Title
Perioperative complications
Description
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
Time Frame
Within 1 month after the surgery
Title
Major cardiovascular events
Description
Death, Nonfatal myocardial infarction, re-admission because of heart disease
Time Frame
Within 6 months post operation
Title
Rate of new onset stroke
Description
New onset of stroke after the surgery, identified by CT or MRI.
Time Frame
Within 6 months post operation
Title
Left ventricular systolic function
Description
Evaluated by ejection fraction from echocardiogram
Time Frame
At 6 months post operation
Title
Costs of treatment
Description
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.
Time Frame
From surgery to 6 months after the surgery
Title
Serum NT-proBNP level
Description
The level of serum NT-proBNP
Time Frame
At 6 months post operation
Title
Quality of life evaluated by short form 36 questionnaire
Time Frame
At 6 months post operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Isolated atrial fibrillation, without structural heart disease.
Failed medical treatment
Patient admitted with intent to be treated by surgical ablation
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiaquan Zhu, MD & Ph.D
Phone
86-13651951806
Email
dr_zhujq@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaosheng Wang, MD & Ph.D
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
23122696
Citation
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.
Results Reference
background
PubMed Identifier
22082673
Citation
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.
Results Reference
background
PubMed Identifier
26003961
Citation
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.
Results Reference
background
PubMed Identifier
30698685
Citation
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.
Results Reference
background
PubMed Identifier
30118714
Citation
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.
Results Reference
background
PubMed Identifier
16434271
Citation
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.
Results Reference
background
PubMed Identifier
30647968
Citation
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.
Results Reference
background
PubMed Identifier
17984136
Citation
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.
Results Reference
background
Learn more about this trial
Concomitant Focal Epicardial Cryoablation During Mei Mini Maze Procedure in Treatment of Lone Atrial Fibrillation
We'll reach out to this number within 24 hrs