Liner Ablation Using Contact-force in Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

— LIBCAAF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03091972
• Other study ID #: LIBCAAF study
• Status: Recruiting
• Phase: N/A
• First received: January 31, 2017
• Last updated: March 21, 2017
• Start date: November 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2017
• Source: Korea University Anam Hospital
• Contact: Seung-Young Roh, MD
• Phone: +82-10-3612-6876
• Email: rsy008[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Pulmonary vein isolation
A pulmonary vein isolation procedure will be performed using radiofrequency ablation with contact force monitoring.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Medical Center Anam hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	Biosense Webster, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (9)

Andreu D, Gomez-Pulido F, Calvo M, Carlosena-Remírez A, Bisbal F, Borràs R, Benito E, Guasch E, Prat-Gonzalez S, Perea RJ, Brugada J, Berruezo A, Mont L. Contact force threshold for permanent lesion formation in atrial fibrillation ablation: A cardiac mag — View Citation

Fassini G, Riva S, Chiodelli R, Trevisi N, Berti M, Carbucicchio C, Maccabelli G, Giraldi F, Bella PD. Left mitral isthmus ablation associated with PV Isolation: long-term results of a prospective randomized study. J Cardiovasc Electrophysiol. 2005 Nov;16 — View Citation

Gaita F, Caponi D, Scaglione M, Montefusco A, Corleto A, Di Monte F, Coin D, Di Donna P, Giustetto C. Long-term clinical results of 2 different ablation strategies in patients with paroxysmal and persistent atrial fibrillation. Circ Arrhythm Electrophysio — View Citation

Hocini M, Jaïs P, Sanders P, Takahashi Y, Rotter M, Rostock T, Hsu LF, Sacher F, Reuter S, Clémenty J, Haïssaguerre M. Techniques, evaluation, and consequences of linear block at the left atrial roof in paroxysmal atrial fibrillation: a prospective random — View Citation

Kautzner J, Neuzil P, Lambert H, Peichl P, Petru J, Cihak R, Skoda J, Wichterle D, Wissner E, Yulzari A, Kuck KH. EFFICAS II: optimization of catheter contact force improves outcome of pulmonary vein isolation for paroxysmal atrial fibrillation. Europace. — View Citation

le Polain de Waroux JB, Weerasooriya R, Anvardeen K, Barbraud C, Marchandise S, De Meester C, Goesaert C, Reis I, Scavee C. Low contact force and force-time integral predict early recovery and dormant conduction revealed by adenosine after pulmonary vein — View Citation

Reddy VY, Dukkipati SR, Neuzil P, Natale A, Albenque JP, Kautzner J, Shah D, Michaud G, Wharton M, Harari D, Mahapatra S, Lambert H, Mansour M. Randomized, Controlled Trial of the Safety and Effectiveness of a Contact Force-Sensing Irrigated Catheter for — View Citation

Santucci PA. Linear ablation of atrial fibrillation: what does it do? Heart Rhythm. 2010 Dec;7(12):1738-9. doi: 10.1016/j.hrthm.2010.09.001. — View Citation

Willems S, Klemm H, Rostock T, Brandstrup B, Ventura R, Steven D, Risius T, Lutomsky B, Meinertz T. Substrate modification combined with pulmonary vein isolation improves outcome of catheter ablation in patients with persistent atrial fibrillation: a pros — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial fibrillation/atrial tachycardia	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	Total radiofrequency energy	Total radiofrequency energy to achieve bidirectional block of linear lesion in left atrium	12 months
Secondary	Total force value	Total force value for complete block of linear lesion	12 months