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

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ClinicalTrials.gov Identifier: NCT02968056
Recruitment Status : Not yet recruiting
First Posted : November 18, 2016
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Ju Mei, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Procedure: Radiofrequency ablation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: One Staged Hybrid Approach of Minimally Invasively Surgical/Catheter Ablation for Persistent Atrial Fibrillation: A Non-Randomized Controlled Trial
Study Start Date : November 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Off any antiarrhythmic drug rate [ Time Frame: 6 months after the surgery ]
    The rate is counted at 6 months

  2. 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

  3. Major cardiovascular events [ Time Frame: Within 6 months after discharge ]
    Death, Nonfatal myocardial infarction, re-admission because of heart disease

  4. Stroke [ Time Frame: Within 6 months after the surgery ]
    New onset of stroke after the surgery

  5. Left ventricular systolic function [ Time Frame: At 6 months after the surgery ]
    Evaluated by ejection fraction from echocardiogram

  6. 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.

  7. Serum brain natriuretic peptide level [ Time Frame: 6 months after the surgery ]
  8. Quality of life [ Time Frame: 6 months after the surgery ]
    Evaluated by short form 36 questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968056


Contacts
Contact: Ju Mei, MD and PhD 86-21-25078030 ju_mei63@126.com
Contact: Jiaquan Zhu, MD and PhD 86-21-25078051 somzjq@126.com

Locations
China, Shanghai
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting
Shanghai, Shanghai, China
Contact: Ju Mei, MD and PhD         
Sponsors and Collaborators
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:
Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. Europace. 2012 Apr;14(4):528-606. doi: 10.1093/europace/eus027. Epub 2012 Mar 1.

Responsible Party: Ju Mei, Professor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02968056     History of Changes
Other Study ID Numbers: XH-16-027
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ju Mei, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
atrial fibrillation
radiofrequency ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes