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Additional Linear Ablation Beyond Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT02637453
Recruitment Status : Recruiting
First Posted : December 22, 2015
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Yi-Gang Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
Pulmonary vein(PV) isolation has become the cornerstone of radiofrequency ablation for AF. However, recent reports have clearly shown that the longer the follow-up period, the lower the success rate with a single ablation procedure. In 5-year follow-up, the mean success rate was only about 45%. The purpose of the study to investigate whether the linear ablation perpendicular to the PV ostium on the basis of circumferential pulmonary vein isolation, can reduce recurrence rate of AF. All patients will be followed up for 12 months. And fourteen days Holter will be performed at the end of follow-up.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Procedure: CPVI Procedure: CPVI+ALA Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Additional Linear Ablation Perpendicular to the Pulmonary Vein Isolation Line Reduces the Recurrence Rate of Paroxysmal Atrial Fibrillation (ALA-PAF)
Study Start Date : June 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CPVI
Only circumferential pulmonary vein isolation(CPVI) was performed for these patients.
Procedure: CPVI
patients with circumferential pulmonary vein isolation (CPVI)

Experimental: CPVI+ALA
Besides circumferential pulmonary vein isolation(CPVI), additional linear ablation(ALA) perpendicular to the pulmonary vein ostium was performed for these patients, ie. CPVI+ALA.
Procedure: CPVI+ALA
patients with circumferential pulmonary vein isolation(CPVI)and additional linear ablation perpendicular to the PV ostium (ALA)




Primary Outcome Measures :
  1. Recurrence rate of atrial fibrillation(Af) in 12-month follow-up [ Time Frame: monthly up to 12 months ]

Secondary Outcome Measures :
  1. The proportion of the observed time that a patient is in AF [ Time Frame: 12 months after ablation procedure ]
    The proportion of the observed time that a patient is in AF, when the fourteen days Holter is performed at the end of follow-up.

  2. Incidence of pulmonary vein stenosis, cardiac tamponade, phrenic nerve and embolism [ Time Frame: monthly up to 12 months ]
  3. Improvement of life quality (SF-36 questionnaire) [ Time Frame: monthly up to 12 months ]
  4. Major cardiovascular events: heart failure, stroke, hospitalization and cardiovascular death [ Time Frame: monthly up to 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. With a history of paroxysmal Af(PAF) and PAF record within 6 months prior to ablation, confirming at least one of the following findings:

    AF lasting for ≥30 s recorded in Holter or 12-lead ECG

  2. No response to more than one antiarrhythmic drug, or unwilling to receive long-term drug treatment.
  3. Can provide informed consent form expressing willingness to participate in the study and comply with follow-up tests and evaluation procedures.
  4. Aged 18-80 years.

Exclusion Criteria:

  1. With acute diseases, such as acute phase after myocardial infarction (within 3 months), within 3 months after acute heart failure or new cerebral infarction;
  2. In the list of heart transplantation;
  3. Expected survival less than 1 year;
  4. With other hemorrhagic diseases and anticoagulant therapy is not allowed;
  5. Thrombosis in left atrium;
  6. Heart failure, New York Heart Association(NYHA) III/IV or eject fraction(EF)<40%;
  7. Patients with uncontrolled cancer;
  8. Significant hepatic or renal impairment (and/or alanine transaminase(ALT) or Aspartate transaminase(AST) >2 times upper limit of normal, creatinine clearance rate(CCr)<50%);
  9. Previous catheter radiofrequency ablation for AF or cardiac surgery;
  10. Pregnant and lactating women, women who plan to become pregnant, or women of child bearing age not using reliable contraceptive measures.

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): NCT02637453


Contacts
Contact: Yi-Gang Li, MD. 13761318166 drliyigang@outlook.com
Contact: Jian Sun, MD. 15801816064 ep-sunjian@vip.163.com

Locations
China, Shanghai
Xinhua Hospital, Shanghai Jiao Tong University School of Medicne Recruiting
Shanghai, Shanghai, China, 200092
Contact: Yi-Gang Li, MD.    13761318166    drliyigang@outlook.com   
Contact: Jian Sun, MD.    15801816064    ep-sunjian@vip.163.com   
Principal Investigator: Yi-Gang Li, MD         
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Yi-Gang Li, MD. Department of Cardiology, Xinhua Hospital, Shanghai Jiaotong University School of Medicne

Publications of Results:

Other 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; Heart Rhythm Society Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. 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: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society. Heart Rhythm. 2012 Apr;9(4):632-696.e21. doi: 10.1016/j.hrthm.2011.12.016. Epub 2012 Mar 1.

Responsible Party: Yi-Gang Li, Professor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02637453     History of Changes
Other Study ID Numbers: ShanghaiXinhua-Af
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015

Keywords provided by Yi-Gang Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Paroxysmal Atrial Fibrillation;Additional Linear Ablation

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