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

Primary Purpose

Persistent Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pulmonary vein isolation
Contact force assisted left atrial linear ablation
left atrial linear ablation without contact force monitoring
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Persistent Atrial Fibrillation, Linear ablation, Catheter ablation, Contact force

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Korea University Medical Center Anam hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Contact force assisted linear ablation

control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total radiofrequency energy
Total radiofrequency energy to achieve bidirectional block of linear lesion in left atrium
Total force value
Total force value for complete block of linear lesion

Full Information

First Posted
January 31, 2017
Last Updated
March 21, 2017
Sponsor
Korea University Anam Hospital
Collaborators
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03091972
Brief Title
Liner Ablation Using Contact-force in Atrial Fibrillation
Acronym
LIBCAAF
Official Title
Left Atrial Liner Block Using Contact-force Catheter in Ablation for Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital
Collaborators
Biosense Webster, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Persistent Atrial Fibrillation, Linear ablation, Catheter ablation, Contact force

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Contact force assisted linear ablation
Arm Type
Experimental
Arm Description
Left atrial linear ablation performed using the contact force sensing catheter after pulmonary vein isolation
Arm Title
control
Arm Type
Active Comparator
Arm Description
Left atrial linear ablation performed using the catheter without contact force sensing after pulmonary vein isolation
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation
Intervention Description
A pulmonary vein isolation procedure will be performed using radiofrequency ablation with contact force monitoring.
Intervention Type
Procedure
Intervention Name(s)
Contact force assisted left atrial linear ablation
Intervention Description
Left atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation monitoring contact force.
Intervention Type
Procedure
Intervention Name(s)
left atrial linear ablation without contact force monitoring
Intervention Description
Left atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation without monitoring contact force.
Primary Outcome Measure Information:
Title
Freedom from atrial fibrillation/atrial tachycardia
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Total radiofrequency energy
Description
Total radiofrequency energy to achieve bidirectional block of linear lesion in left atrium
Time Frame
12 months
Title
Total force value
Description
Total force value for complete block of linear lesion
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung-Young Roh, MD
Phone
+82-10-3612-6876
Email
rsy008@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kwang No Lee, MD
Phone
+82-10-9286-1123
Email
knlee81@naver.com
Facility Information:
Facility Name
Korea University Medical Center Anam hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Hoon Kim, President
Phone
+82-2-920-5445
Email
yhkmd@unitel.co.kr

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
16302895
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(11):1150-6. doi: 10.1111/j.1540-8167.2005.50192.x.
Results Reference
result
PubMed Identifier
16344401
Citation
Hocini M, Jais P, Sanders P, Takahashi Y, Rotter M, Rostock T, Hsu LF, Sacher F, Reuter S, Clementy J, Haissaguerre M. Techniques, evaluation, and consequences of linear block at the left atrial roof in paroxysmal atrial fibrillation: a prospective randomized study. Circulation. 2005 Dec 13;112(24):3688-96. doi: 10.1161/CIRCULATIONAHA.105.541052.
Results Reference
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PubMed Identifier
16782716
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 prospective randomized comparison. Eur Heart J. 2006 Dec;27(23):2871-8. doi: 10.1093/eurheartj/ehl093. Epub 2006 Jun 16.
Results Reference
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PubMed Identifier
19808418
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 Electrophysiol. 2008 Oct;1(4):269-75. doi: 10.1161/CIRCEP.108.774885.
Results Reference
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PubMed Identifier
20817018
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. Epub 2010 Sep 28. No abstract available.
Results Reference
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PubMed Identifier
26041872
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. 2015 Aug;17(8):1229-35. doi: 10.1093/europace/euv057. Epub 2015 Jun 3.
Results Reference
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PubMed Identifier
26260733
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 Ablation of Paroxysmal Atrial Fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study. Circulation. 2015 Sep 8;132(10):907-15. doi: 10.1161/CIRCULATIONAHA.114.014092. Epub 2015 Aug 10.
Results Reference
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PubMed Identifier
26272524
Citation
Andreu D, Gomez-Pulido F, Calvo M, Carlosena-Remirez A, Bisbal F, Borras 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 magnetic resonance-based study to detect ablation gaps. Heart Rhythm. 2016 Jan;13(1):37-45. doi: 10.1016/j.hrthm.2015.08.010. Epub 2015 Aug 10.
Results Reference
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PubMed Identifier
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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 isolation. Europace. 2015 Jun;17(6):877-83. doi: 10.1093/europace/euu329. Epub 2015 Jan 24.
Results Reference
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Liner Ablation Using Contact-force in Atrial Fibrillation

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