Lone Atrial FibrillationNCT04522024
Concomitant Focal Epicardial Cryoablation During Mei Mini Maze Procedure in Treatment of Lone Atrial Fibrillation
A study testing Epicardial focal cryoablation and Mei Mini Maze procedure in people with Lone Atrial Fibrillation, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lone Atrial Fibrillation
- What is being tested?
- Epicardial focal cryoablation and Mei Mini Maze procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated atrial fibrillation, without structural heart disease.
- Failed medical treatment
- Patient admitted with intent to be treated by surgical ablation
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Concomitant Focal Epicardial Cryoablation During Mei Mini Maze Procedure in Treatment of Lone Atrial Fibrillation: A Randomized Controlled Trial
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
- Being tested
- Epicardial focal cryoablation, Mei Mini Maze procedure
- Keywords
- epicardial cryoablation, epicardial radiofrequency ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epicardial focal cryoablationProcedure or surgery
Epicardial focal cryoablation on the left atrium around right upper pulmonary vein area
Mei Mini Maze procedureProcedure or surgery
Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side
| Study group | Role | What they receive |
|---|---|---|
| Mei Mini Maze | Active comparator | Mei Mini Maze procedure (Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side) Receives: Procedure: Mei Mini Maze procedure |
| Mei Mini Maze plus epicardial cryoablation | Experimental | Epicardial focal cryoablation during Mei Mini Maze procedure Receives: Procedure: Epicardial focal cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 6 months post operation
Secondary outcomes (8)
Off any antiarrhythmic drug rate
Off any antiarrhythmic drug rate
Measured: At 6 months post operation
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
Measured: Within 1 month after the surgery
Major cardiovascular events
Death, Nonfatal myocardial infarction, re-admission because of heart disease
Measured: Within 6 months post operation
Rate of new onset stroke
New onset of stroke after the surgery, identified by CT or MRI.
Measured: Within 6 months post operation
Left ventricular systolic function
Evaluated by ejection fraction from echocardiogram
Measured: At 6 months post operation
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.
Measured: From surgery to 6 months after the surgery
Serum NT-proBNP level
The level of serum NT-proBNP
Measured: At 6 months post operation
Quality of life evaluated by short form 36 questionnaire
Measured: At 6 months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lone Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiaquan Zhu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yaosheng Wang, MD & Ph.D, Study director, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522024
- Sponsor's protocol ID
- XH-20-019
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23122696Boersma 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.
PubMed 22082673Phan 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.
PubMed 26003961van 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.
PubMed 30698685Cox 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.
PubMed 30118714Milla 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.
PubMed 16434271Wang 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.
PubMed 30647968Blomstrom-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.
PubMed 17984136
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Focal Epicardial Cryoablation During Mei Mini Maze Procedure in Treatment of Lone Atrial Fibrillation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04522024
- Acronym / sponsor ID
- XH-20-019
- Conditions
- Lone Atrial Fibrillation
- Keywords
- epicardial cryoablation, epicardial radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mei Mini Maze | Active comparator | Procedure: Mei Mini Maze procedureMei Mini Maze procedure (Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side) |
| Mei Mini Maze plus epicardial cryoablation | Experimental | Procedure: Epicardial focal cryoablationEpicardial focal cryoablation during Mei Mini Maze procedure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Isolated atrial fibrillation, without structural heart disease.
- Failed medical treatment
- Patient admitted with intent to be treated by surgical ablation
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epicardial focal cryoablationEpicardial focal cryoablation on the left atrium around right upper pulmonary vein area | Procedure or surgery | Mei Mini Maze plus epicardial cryoablation |
| Mei Mini Maze procedureUnilateral thoracoscopic epicardial ablation by radiofrequency energy from left side | Procedure or surgery | Mei Mini Maze |
Primary outcome
Sinus rhythm maintenance rate
Time frame: 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
8 secondary outcomes
Off any antiarrhythmic drug rate
Time frame: At 6 months post operation
Perioperative complications
Time frame: Within 1 month after the surgery
Major cardiovascular events
Time frame: Within 6 months post operation
Rate of new onset stroke
Time frame: Within 6 months post operation
Left ventricular systolic function
Time frame: At 6 months post operation
Costs of treatment
Time frame: From surgery to 6 months after the surgery
Serum NT-proBNP level
Time frame: At 6 months post operation
Quality of life evaluated by short form 36 questionnaire
Time frame: At 6 months post operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Background: PubMed 23122696Mei 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.
- Background: PubMed 22082673Boersma 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.
- Background: PubMed 26003961Phan 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.
- Background: PubMed 30698685van 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.
- Background: PubMed 30118714Cox 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.
- Background: PubMed 16434271Milla 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.
- Background: PubMed 30647968Wang 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.
- Background: PubMed 17984136Blomstrom-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaosheng Wang, MD & Ph.D study director
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Epicardial focal cryoablation and Mei Mini Maze procedure in people with Lone Atrial Fibrillation, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiaquan Zhu, MD & Ph.D (86-13651951806, dr_zhujq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinus rhythm maintenance rate (time frame: At 6 months post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04522024, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.