One Staged Hybrid Approach of Surgical/Catheter Ablation for Persistent Atrial Fibrillation

June 13, 2018 updated by: Ju Mei, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

One Staged Hybrid Approach of Minimally Invasively Surgical/Catheter Ablation for Persistent Atrial Fibrillation: A Non-Randomized Controlled Trial

There are 10 million atrial fibrillation (AF) patients in China, and the patients are risk of stroke, heart failure and sudden death. Persistent AF is still a refractory disease, and single catheter ablation only has a success rate around 30-50%. Hybrid strategy consisting of thoracoscopic epicardial ablation and transvenous endocardial ablation seems to be an attractive procedure to improve the treatment of persistent AF. However, only a few centers reported their preliminary results, and the conclusions are controversial. The investigator previously reported a minimally invasive surgical ablation from left thoracoscope only and achieved good results. Recently, the investigator successfully explored a hybrid procedure combing this unique surgical technique and transvenous catheter ablation. Here, the investigator present a study to evaluate the efficacy and safety of this novel hybrid procedure. The hypothesis is that a hybrid approach is more efficient than surgical ablation alone in the treatment of persistent AF.

This study is a non-randomized controlled study within a single institution. Isolated persistent AF patients admitted to the cardiovascular surgery department of Shanghai Xinhua Hospital will be screened for enrollment of this study. The study will recruit 180 patients in total. Based on their own willingness, the patients will be divided into hybrid group and minimally invasive (MIS) group. The MIS group patients only have surgical ablation surgery from left thoracoscope as the investigator reported before, while the hybrid group patients will have additional transvenous catheter ablation after the surgical ablation is done during the same operation. The ratio of hybrid to MIS group is expected to be 1:1, so that each group contains 90 patients. The perioperative data is collected, and the patients will be followed for 6 months. The primary outcome is the rate 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 is to evaluate the efficacy and safety of this novel hybrid procedure, therefore to provide more evidence of the hybrid strategy in the treatment of persistent AF.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

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 Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Ju Mei, MD and PhD

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Isolated atrial fibrillation, without structural heart disease.
  2. Persistent atrial fibrillation (Af last time > 7 days, including persistent long standing atrial fibrillation)
  3. Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication; symptomatic patients are those who have been aware of their AF at any time within the last 5 years before enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of these.
  4. Patient admitted with intent to treat by either hybrid or surgical ablation
  5. Consent

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 1-year 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hybrid group
Minimally invasive surgical radiofrequency ablation of atrial fibrillation followed by catheterized radiofrequency ablation within the same procedure
Procedure: Radiofrequency ablation
Radiofrequency energy is used for ablation in both arms of this study (Hybrid group and MIS group)
Active Comparator: MIS group
Minimally invasive surgical radiofrequency ablation of atrial fibrillation only
Procedure: Radiofrequency ablation
Radiofrequency energy is used for ablation in both arms of this study (Hybrid group and MIS group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sinus rhythm maintenance rate
Time Frame: At 6 months after the surgery
Based on ECG results from 3 months and 6 months 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 after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Off any antiarrhythmic drug rate
Time Frame: 6 months after the surgery
The rate is counted at 6 months
6 months after the surgery
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
Major cardiovascular events
Time Frame: Within 6 months after discharge
Death, Nonfatal myocardial infarction, re-admission because of heart disease
Within 6 months after discharge
Stroke
Time Frame: Within 6 months after the surgery
New onset of stroke after the surgery
Within 6 months after the surgery
Left ventricular systolic function
Time Frame: At 6 months after the surgery
Evaluated by ejection fraction from echocardiogram
At 6 months after the surgery
Costs of treatment in Chinese Yuan
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 brain natriuretic peptide level
Time Frame: 6 months after the surgery
6 months after the surgery
Quality of life
Time Frame: 6 months after the surgery
Evaluated by short form 36 questionnaire
6 months after the surgery

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: Xin Zhou, MD, 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 (Actual)

December 1, 2016

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

November 13, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-16-027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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