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

March 21, 2017 updated by: Young-Hoon Kim, Korea University Anam Hospital

Left Atrial Liner Block Using Contact-force Catheter in Ablation for Atrial Fibrillation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Seung-Young Roh, MD
  • Phone Number: +82-10-3612-6876
  • Email: rsy008@gmail.com

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Medical Center Anam hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total radiofrequency energy
Time Frame: 12 months
Total radiofrequency energy to achieve bidirectional block of linear lesion in left atrium
12 months
Total force value
Time Frame: 12 months
Total force value for complete block of linear lesion
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Collaborators

Biosense Webster, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 27, 2017

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIBCAAF study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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