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Status unknownNCT03091972LIBCAAFUpdated Mar 27, 2017

Liner Ablation Using Contact-force in Atrial Fibrillation

An interventional study of Pulmonary vein isolation and Contact force assisted left atrial linear ablation in Persistent Atrial Fibrillation, sponsored by Korea University Anam Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-27.

Sponsored by Korea University Anam Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Persistent Atrial Fibrillation

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Keywords

  • Persistent Atrial Fibrillation
  • Linear ablation
  • Catheter ablation
  • Contact force
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 200 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Korea University Anam Hospital is the lead sponsor of 110 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Contact force assisted linear ablation

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

    Procedure: Pulmonary vein isolation · Procedure: Contact force assisted left atrial linear ablation

  • Active comparator
    control

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

    Procedure: Pulmonary vein isolation · Procedure: left atrial linear ablation without contact force monitoring

Interventions

  • ProcedurePulmonary vein isolation

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

  • ProcedureContact 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.

  • Procedureleft 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

Secondary outcomes

  1. Total radiofrequency energy

    Total radiofrequency energy to achieve bidirectional block of linear lesion in left atrium

    Time frame: 12 months

  2. Total force value

    Total force value for complete block of linear lesion

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Korea University Medical Center Anam hospital
    Seoul, 02841, Korea, Republic of
    Recruiting
08

References and documents

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 16302895 ↗
  • 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. PubMed 16344401 ↗
  • 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. PubMed 16782716 ↗
  • 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. PubMed 19808418 ↗
  • 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. PubMed 20817018 ↗
  • 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. PubMed 26041872 ↗
  • 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. PubMed 26260733 ↗
  • 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. PubMed 26272524 ↗
  • 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. PubMed 25618742 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03091972
Lead sponsor
Korea University Anam Hospital
Collaborators
Biosense Webster, Inc.
Responsible party
Young-Hoon Kim (Professor, Korea University Anam Hospital) — Principal investigator
First posted
Mar 27, 2017
Start date
Nov 1, 2016
Primary completion
Dec 31, 2017 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Mar 27, 2017

Study contacts

Seung-Young Roh, MD
Contact
rsy008@gmail.com
+82-10-3612-6876
Kwang No Lee, MD
Contact
knlee81@naver.com
+82-10-9286-1123

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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