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

Korea University

Status: Unknown

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: left atrial linear ablation without contact force monitoring; Procedure: Contact force assisted left atrial linear ablation; Procedure: Pulmonary vein isolation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03091972

LIBCAAF study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Contact force assisted linear ablation

Experimental group

Description:

Left atrial linear ablation performed using the contact force sensing catheter after pulmonary vein isolation

Treatment:

Procedure: Contact force assisted left atrial linear ablation

Procedure: Pulmonary vein isolation

control

Active Comparator group

Description:

Left atrial linear ablation performed using the catheter without contact force sensing after pulmonary vein isolation

Treatment:

Procedure: left atrial linear ablation without contact force monitoring

Procedure: Pulmonary vein isolation