Persistent Atrial FibrillationLIBCAAFNCT03091972
Liner Ablation Using Contact-force in Atrial Fibrillation
A study testing Pulmonary vein isolation, Contact force assisted left atrial linear ablation and left atrial linear ablation without contact force monitoring in people with Persistent Atrial Fibrillation, run by Korea University Anam Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Pulmonary vein isolation, Contact force assisted left atrial linear ablation and left atrial linear ablation without contact force monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Medical Center Anam hospital
Seoul, 02841
Young-Hoon Kim, President, +82-2-920-5445, yhkmd@unitel.co.kr
About this study
Official title: 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.
Read the 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.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Pulmonary vein isolation, Contact force assisted left atrial linear ablation, left atrial linear ablation without contact force monitoring
- Keywords
- Persistent Atrial Fibrillation, Linear ablation, Catheter ablation, Contact force
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationProcedure or surgery
A pulmonary vein isolation procedure will be performed using radiofrequency ablation with contact force monitoring.
Contact force assisted left atrial linear ablationProcedure or surgery
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 monitoringProcedure or surgery
Left atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation without monitoring contact force.
| Study group | Role | What they receive |
|---|---|---|
| Contact force assisted linear ablation | Experimental | Left atrial linear ablation performed using the contact force sensing catheter after pulmonary vein isolation Receives: Procedure: Pulmonary vein isolation; Procedure: Contact force assisted left atrial linear ablation |
| control | Active comparator | Left atrial linear ablation performed using the catheter without contact force sensing after pulmonary vein isolation Receives: Procedure: Pulmonary vein isolation; Procedure: left atrial linear ablation without contact force monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
Total radiofrequency energy
Total radiofrequency energy to achieve bidirectional block of linear lesion in left atrium
Measured: 12 months
Total force value
Total force value for complete block of linear lesion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start1 Nov 2016
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Principal investigator, Young-Hoon Kim, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091972
- Sponsor's protocol ID
- LIBCAAF study
- Acronym
- LIBCAAF
- Status last verified
- Mar 2017
- First submitted
- 31 Jan 2017
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 16302895Hocini 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.
PubMed 16344401Willems 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.
PubMed 16782716Gaita 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.
PubMed 19808418Santucci 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.
PubMed 20817018Kautzner 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.
PubMed 26041872Reddy 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.
PubMed 26260733Andreu 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.
PubMed 26272524le 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.
PubMed 25618742
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Liner Block Using Contact-force Catheter in Ablation for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03091972
- Acronym / sponsor ID
- LIBCAAF / LIBCAAF study
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Persistent Atrial Fibrillation, Linear ablation, Catheter ablation, Contact force
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contact force assisted linear ablation | Experimental | Procedure: Pulmonary vein isolation, Procedure: Contact force assisted left atrial linear ablationLeft atrial linear ablation performed using the contact force sensing catheter after pulmonary vein isolation |
| control | Active comparator | Procedure: Pulmonary vein isolation, Procedure: left atrial linear ablation without contact force monitoringLeft atrial linear ablation performed using the catheter without contact force sensing after pulmonary vein isolation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary vein isolationA pulmonary vein isolation procedure will be performed using radiofrequency ablation with contact force monitoring. | Procedure or surgery | Contact force assisted linear ablation, control |
| Contact force assisted left atrial linear ablationLeft atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation monitoring contact force. | Procedure or surgery | Contact force assisted linear ablation |
| left atrial linear ablation without contact force monitoringLeft atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation without monitoring contact force. | Procedure or surgery | control |
Primary outcome
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
2 secondary outcomes
Total radiofrequency energy
Time frame: 12 months
Total force value
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Results publication: PubMed 16302895Fassini 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 publication: PubMed 16344401Hocini 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 publication: PubMed 16782716Willems 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 publication: PubMed 19808418Gaita 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 publication: PubMed 20817018Santucci 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 publication: PubMed 26041872Kautzner 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 publication: PubMed 26260733Reddy 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 publication: PubMed 26272524Andreu 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 publication: PubMed 25618742le 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation, Contact force assisted left atrial linear ablation and left atrial linear ablation without contact force monitoring in people with Persistent Atrial Fibrillation, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung-Young Roh, MD (+82-10-3612-6876, rsy008@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial fibrillation/atrial tachycardia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03091972, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017; AzTrials last refreshed its copy on 30 Oct 2026.