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Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial (LEAP-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04405258
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Institute for Clinical Effectiveness, Japan

Brief Summary:
The purpose for this study is to determine whether left posterior wall isolation (PWI) in addition to pulmonary vein isolation (PVI) is effective as ablation strategy for persistent atrial fibrillation (AF).

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Catheter Ablation Pulmonary Vein Isolation Posterior Wall Isolation Procedure: Pulmonary vein isolation Procedure: Left posterior wall isolation Phase 4

Detailed Description:
PVI is cornerstone of AF ablation. However, clinical outcome of only PVI in patients with persistent AF is insufficient due to AF substrate extending to left atrium. Strategy of catheter ablation for persistent AF is not established despite attempts of numerous left atrial substrate modifications. Additional PWI on PVI is one of expected effective strategies for persistent AF, because PW originated from common tissue of PV and is considered to play a part in AF trigger and maintenance. However, this strategy is also not established in the recent international consensus statement. Following two reasons are considered. One is the procedural difficulty in creating durable PWI, and another is the existence of patients who can recover by only PVI. The latest technology, ablation index, can create durable PVI, and may create durable PWI. Several reports suggested that PVI only strategy was sufficient in the patients with persistent AF who could maintain sinus rhythm after pharmacological or electrical cardioversion. Therefore, we planed this randomized clinical trial that compared between PVI alone and additional PWI on PVI using ablation index in the patients with persistent AF without pharmacological sinus rhythm conversion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Additional Left Atrial Posterior Wall Isolation for Persistent Atrial Fibrillation
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PVI alone
Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation
Procedure: Pulmonary vein isolation
Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation

Active Comparator: PVI and PWI
Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation
Procedure: Left posterior wall isolation
Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation




Primary Outcome Measures :
  1. Recurrence of atrial tachyarrhythmia after 90-day blanking period of catheter ablation [ Time Frame: 18 months ]
    Recurrence of atrial tachyarrhythmia is defined atrial arrhythmia that needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.


Secondary Outcome Measures :
  1. Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of catheter ablation [ Time Frame: 18 months ]
    Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.

  2. Recurrence of atrial fibrillation or atrial tachycardia within 90-day after catheter ablation [ Time Frame: 90 days ]
    Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.

  3. Repeated ablation of atrial tachyarrhythmia [ Time Frame: 18 months ]
  4. Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of repeated ablation [ Time Frame: 18 months ]
  5. Atrial Fibrillation Quality of Life Questionnaire [ Time Frame: 18 months ]
    Atrial Fibrillation Quality of Life Questionnaire

  6. Complications of ablation procedure [ Time Frame: 1 month ]
    Complications of ablation procedure includes death, cardiac tamponade, pericardial effusion, systemic embolism, symptomatic strokes, hematoma, A-V shunt, pericarditis, phrenic nerve paralysis, A-V block, procedure-related infections, heart failure, atrio-esophageal fistula, esophageal vagus nerve injury



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

Inclusion Criteria:

  • Patients scheduled for first catheter ablation of persistent atrial fibrillation
  • Patients without conversion to sinus rhythm within 30 days after antiarrhythmic drug administration
  • Patients with persisting duration of atrial fibrillation less than 3 years
  • Patients with left atrial diameter less than 50mm
  • Patients who can be followed up for 18 months
  • Patients with written informed consent

Exclusion Criteria:

  • Patients who can not be received adequate anticoagulation therapy
  • Patients with history of myocardial infarction within 6 months
  • Patients with history of open heart surgery
  • Patients scheduled for open heart surgery
  • Patients with severe valvular heart disease
  • Patients during pregnancy
  • Patients with expected life expectancy less than 1 year due to malignancy or non-cardiovascular disease
  • Patients considered unsuitable for study by the attending physician

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): NCT04405258


Contacts
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Contact: Keisuke Okawa, MD +81-87-811-3333 ext 5555 k-ookawa@chp-kagawa.jp
Contact: Masahiko Takahashi, MD +81-87-811-3333 ext 5558 ma-takahashi@chp-kagawa.jp

Locations
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Japan
Kagawa Prefectural Central Hospital Recruiting
Takamatsu, Kagawa, Japan, 760-8557
Contact: Keisuke Okawa, MD    +81-87-811-3333 ext 5555    k-ookawa@chp-kagawa.jp   
Contact: Masahiko Takahashi, MD    +81-87-811-3333 ext 5558    ma-takahashi@chp-kagawa.jp   
Sponsors and Collaborators
Institute for Clinical Effectiveness, Japan
Investigators
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Principal Investigator: Keisuke Okawa, MD Kagawa Prefectural Central Hospital
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Responsible Party: Institute for Clinical Effectiveness, Japan
ClinicalTrials.gov Identifier: NCT04405258    
Other Study ID Numbers: 947
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data that support the findings of this study will be available from the data center upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute for Clinical Effectiveness, Japan:
Persistent atrial fibrillation
Catheter ablation
Pulmonary vein isolation
Posterior wall isolation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes