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Liner Ablation Using Contact-force in Atrial Fibrillation (LIBCAAF)

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ClinicalTrials.gov Identifier: NCT03091972
Recruitment Status : Unknown
Verified March 2017 by Young-Hoon Kim, Korea University Anam Hospital.
Recruitment status was:  Recruiting
First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Young-Hoon Kim, Korea University Anam Hospital

Brief Summary:

Linear ablation is frequently used in the procedure for persistent atrial fibrillation. However, it has a limitation because of technical difficulty. Incomplete block is common and an important cause of atrial tachycardia.

The association between contact force values and successful linear block has not been revealed yet. We aim to the effectiveness and safety of linear ablation by using CF sensing catheter.


Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Procedure: Pulmonary vein isolation Procedure: Contact force assisted left atrial linear ablation Procedure: left atrial linear ablation without contact force monitoring Not Applicable

Detailed Description:

Catheter ablation is currently accepted as a treatment option for symptomatic atrial fibrillation. Linear ablation is frequently used in the procedure for persistent atrial fibrillation. Multiple studies have shown benefit of linear ablation. However, it has a limitation because of technical difficulty. Incomplete block is common and an important cause of atrial tachycardia.

Contact-force (CF) monitoring during procedure has recently been available. This technology appears to significantly decrease procedure time and short term reconnection incidence in pulmonary vein (PV) isolation. It also helped to resolve the cause of PV reconnection. Some reports demonstrated that the association between reconnection and lower CF value.

Linear ablation has more variation to interrupt block and reconnection was more often than PV isolation. The association between CF values and successful linear block has not been revealed yet. In addition, the investigators aim to the effectiveness and safety of linear ablation by using CF sensing catheter.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Left Atrial Liner Block Using Contact-force Catheter in Ablation for Atrial Fibrillation
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Contact force assisted linear ablation
Left atrial linear ablation performed using the contact force sensing catheter after pulmonary vein isolation
Procedure: Pulmonary vein isolation
A pulmonary vein isolation procedure will be performed using radiofrequency ablation with contact force monitoring.

Procedure: Contact force assisted left atrial linear ablation
Left atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation monitoring contact force.

Active Comparator: control
Left atrial linear ablation performed using the catheter without contact force sensing after pulmonary vein isolation
Procedure: Pulmonary vein isolation
A pulmonary vein isolation procedure will be performed using radiofrequency ablation with contact force monitoring.

Procedure: left atrial linear ablation without contact force monitoring
Left atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation without monitoring contact force.




Primary Outcome Measures :
  1. Freedom from atrial fibrillation/atrial tachycardia [ Time Frame: 12 months ]
    Freedom from any documented episode of atrial fibrillation/atrial tachycardia occurring after a single ablation procedure and lasting longer than 30 seconds with/without antiarrhythmic medication


Secondary Outcome Measures :
  1. Total radiofrequency energy [ Time Frame: 12 months ]
    Total radiofrequency energy to achieve bidirectional block of linear lesion in left atrium

  2. Total force value [ Time Frame: 12 months ]
    Total force value for complete block of linear lesion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients age is18 years or greater
  • Patients with persistent AF (AF episode lasting > 7 days)
  • Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication
  • Patients with recurrent or sustained arrhythmia after pulmonary vein isolation
  • Patients undergoing a first-time ablation procedure for AF
  • At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, trans telephonic monitoring (TTM), or implantable device within last 2 years of enrollment in this investigation
  • Patients must be able and willing to provide written informed consent to participate in this investigation

Exclusion Criteria:

  • Patients with long-standing persistent AF;
  • Long-standing persistent AF will be defined as a sustained episode lasting more than 3 years.
  • Patients for whom cardioversion or sinus rhythm will never be attempted/pursued;
  • Patients with AF felt to be secondary to an obvious reversible cause
  • Patients with contraindications to systemic anticoagulation with heparin or warfarin or a direct thrombin inhibitor;
  • Patients with left atrial size ≥ 60 mm (2D echocardiography, parasternal long axis view)
  • Moderate to severe valvular disease
  • Reduced left ventricular function (ejection fraction <40%)
  • Patients who are pregnant. Pregnancy will be assessed by patients informing the physicians.

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): NCT03091972


Contacts
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Contact: Seung-Young Roh, MD +82-10-3612-6876 rsy008@gmail.com
Contact: Kwang No Lee, MD +82-10-9286-1123 knlee81@naver.com

Locations
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Korea, Republic of
Korea University Medical Center Anam hospital Recruiting
Seoul, Korea, Republic of, 02841
Contact: Young-Hoon Kim, President    +82-2-920-5445    yhkmd@unitel.co.kr   
Sponsors and Collaborators
Korea University Anam Hospital
Biosense Webster, Inc.

Publications of Results:

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Responsible Party: Young-Hoon Kim, Professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT03091972     History of Changes
Other Study ID Numbers: LIBCAAF study
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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 Young-Hoon Kim, Korea University Anam Hospital:
Persistent Atrial Fibrillation
Linear ablation
Catheter ablation
Contact force
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes