Liner Ablation Using Contact-force in Atrial Fibrillation

Not Applicable

• Conditions: Persistent Atrial Fibrillation
• Interventions: Procedure: Pulmonary vein isolation; Procedure: Contact force assisted left atrial linear ablation; Procedure: left atrial linear ablation without contact force monitoring

• Registration Number: NCT03091972
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-11-01
• Study First Submitted: 2017-01-31
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-21
• Last Update Submitted: 2017-03-21
• Study First Posted: 2017-03-27
• Last Update Posted: 2017-03-27
• Primary Completion: 2017-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Pulmonary vein isolation	Left atrial linear ablation performed using the catheter without contact force sensing after pulmonary vein isolation
Contact force assisted linear ablation	Contact force assisted left atrial linear ablation	Left atrial linear ablation performed using the contact force sensing catheter after pulmonary vein isolation
control	left atrial linear ablation without contact force monitoring	Left atrial linear ablation performed using the catheter without contact force sensing after pulmonary vein isolation
Contact force assisted linear ablation	Pulmonary vein isolation	Left atrial linear ablation performed using the contact force sensing catheter after pulmonary vein isolation

Primary Outcome Measures

Name	Time	Method
Freedom from atrial fibrillation/atrial tachycardia	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

Name	Time	Method
Total radiofrequency energy	12 months	Total radiofrequency energy to achieve bidirectional block of linear lesion in left atrium
Total force value	12 months	Total force value for complete block of linear lesion

Trial Locations

Locations (1)

Korea University Medical Center Anam hospital; 🇰🇷 Seoul, Korea, Republic of