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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

Tracking Information
First Submitted Date  ICMJE January 31, 2017
First Posted Date  ICMJE March 27, 2017
Last Update Posted Date March 27, 2017
Actual Study Start Date  ICMJE November 1, 2016
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
  • Total radiofrequency energy [ Time Frame: 12 months ]
    Total radiofrequency energy to achieve bidirectional block of linear lesion in left atrium
  • Total force value [ Time Frame: 12 months ]
    Total force value for complete block of linear lesion
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liner Ablation Using Contact-force in Atrial Fibrillation
Official Title  ICMJE Left Atrial Liner Block Using Contact-force Catheter in Ablation for Atrial Fibrillation
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Persistent Atrial Fibrillation
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Contact force assisted linear ablation
    Left atrial linear ablation performed using the contact force sensing catheter after pulmonary vein isolation
    Interventions:
    • Procedure: Pulmonary vein isolation
    • Procedure: Contact force assisted left atrial linear ablation
  • Active Comparator: control
    Left atrial linear ablation performed using the catheter without contact force sensing after pulmonary vein isolation
    Interventions:
    • Procedure: Pulmonary vein isolation
    • Procedure: left atrial linear ablation without contact force monitoring
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 21, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03091972
Other Study ID Numbers  ICMJE LIBCAAF study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Young-Hoon Kim, Korea University Anam Hospital
Study Sponsor  ICMJE Korea University Anam Hospital
Collaborators  ICMJE Biosense Webster, Inc.
Investigators  ICMJE Not Provided
PRS Account Korea University Anam Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP