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

August 20, 2020 updated by: Jiaquan Zhu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jiaquan Zhu, MD & Ph.D
  • Phone Number: 86-13651951806
  • Email: dr_zhujq@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 6 months post operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative complications
Time Frame: 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
Within 1 month after the surgery
Off any antiarrhythmic drug rate
Time Frame: At 6 months post operation
Off any antiarrhythmic drug rate
At 6 months post operation
Major cardiovascular events
Time Frame: Within 6 months post operation
Death, Nonfatal myocardial infarction, re-admission because of heart disease
Within 6 months post operation
Rate of new onset stroke
Time Frame: Within 6 months post operation
New onset of stroke after the surgery, identified by CT or MRI.
Within 6 months post operation
Left ventricular systolic function
Time Frame: At 6 months post operation
Evaluated by ejection fraction from echocardiogram
At 6 months post operation
Costs of treatment
Time Frame: 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.
From surgery to 6 months after the surgery
Serum NT-proBNP level
Time Frame: At 6 months post operation
The level of serum NT-proBNP
At 6 months post operation
Quality of life evaluated by short form 36 questionnaire
Time Frame: At 6 months post operation
At 6 months post operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (Actual)

August 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 21, 2020

Last Update Submitted That Met QC Criteria

August 20, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-20-019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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