Clinical trial NCT02892162: Catheter Ablation Therapy for Persistent Atrial Fibrillation
Official title: Catheter Ablation Therapy for Persistent Atrial Fibrillation: Value of Additional Linear Ablation on Left Atrial Anterior Wall
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: atrial fibrillation
catheter ablation
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Beijing Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: Tianjin Medical University General Hospital
name: Wuhan Asia Heart Hospital
name: First Affiliated Hospital of Kunming Medical University
First posted: 2016-09-08
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Use of catheter ablation for persistent atrial fibrillation (PerAF) remains controversial due to unsatisfactory long-term success rates (15% - 28.4%). The investigators' previous study indicated that the upper area of the left atrium (LA) plays an important role in PerAF, with the LA roof and mitral isthmus appearing to serve as main substrate in progression from PAF to PerAF and maintenance of fibrillatory activities. The investigators therefore hypothesized that AF should not be initiated or sustained if the latter crucial regions for AF maintenance are abolished. This study aimed to describe the efficacy and safety of additional linear ablation on the left atrial anterior wall for PerAF.

Detailed description: Although studies and guidelines have helped establish catheter ablation as preferred treatment for patients suffering from paroxysmal atrial fibrillation (PAF), use of catheter ablation for persistent atrial fibrillation (PerAF) remains controversial due to unsatisfactory long-term success rates (15% - 28.4%).

The investigators' study indicated that the upper area of the left atrium (LA) plays an important role in PerAF, with the LA roof and mitral isthmus appearing to serve as main substrate in progression from PAF to PerAF and maintenance of fibrillatory activities. The investigators therefore hypothesized that AF should not be initiated or sustained if the latter crucial regions for AF maintenance are abolished. This was confirmed using a stepwise pure linear ablation protocol, consisting of a line across the LA roof and extending along the anterior wall of pulmonary veins (PV) antrum to mitral valve annulus (MVA) without PV isolation; the approach appeared safe and effective with long-term (5.2 years) follow-up success rate of 40% for PerAF.

This study will evaluate efficacy and safety of circumferential pulmonary vein isolation (CPVI) + LA roof linear ablation + LA anterior wall (LAAW) linear ablation combined with high density mapping and contact force sensing techniques for perAF. This study is expected to provide a practical and guided catheter ablation strategy with maximized safety and efficacy through use of contact force sensing technique, which will be accepted by other qualified electrophysiology laboratories.

Eligibility criteria: Inclusion Criteria:

- The main inclusion criterion is patients suffering from drug refractory persistent atrial fibrillation and referred to catheter ablation therapy. Persistent AF is defined as continuous AF for over 7 days, or lasting no more than 7 days but requiring pharmacological or electrical cardioversion.

Exclusion Criteria:

1. Patients without spontaneous ongoing AF at the beginning of the procedure;
2. Age: \<18 years or \>70 years;
3. LA size \> 55mm measured on echocardiogram;
4. Previous AF ablation history including surgical ablation;
5. Documented LA thrombus;
6. Severe pulmonary diseases;
7. Previous cardiac surgical history.

Primary outcomes:
measure: AF recurrence
timeFrame: From August, 2016 to July 2019. The overall Time Frame for AF recurrence is being assessed up to 36 months.
Secondary outcomes:
measure: Acute success rate of AF termination during ablation procedure
timeFrame: From August, 2016 to July 2017. The overall Time Frame for AF termination during ablation procedure is being assessed up to 12 months.
measure: Frequency of complications
timeFrame: From August, 2016 to July 2017. The overall Time Frame for frequency of complications is being assessed up to 12 months.
measure: Average radiation exposure
timeFrame: From August, 2016 to July 2017. The overall Time Frame for average radiation exposure is being assessed up to 12 months.
measure: Frequency of redo procedures
timeFrame: From August, 2016 to July 2019. The overall Time Frame for frequency of redo procedures is being assessed up to 12 months.
Other outcomes:
measure: Average ablation time and procedure time
timeFrame: From August, 2016 to July 2017. The overall Time Frame for average ablation time and procedure time are being assessed up to 12 months.
Locations:
city: Beijing
country: China
facility: China National Center for Cardiovascular Diseases
state: Beijing
Study officials:
affiliation: China National Center for Cardiovascular Diseases
name: Yan Yao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Sorgente A, Tung P, Wylie J, Josephson ME. Six year follow-up after catheter ablation of atrial fibrillation: a palliation more than a true cure. Am J Cardiol. 2012 Apr 15;109(8):1179-86. doi: 10.1016/j.amjcard.2011.11.058. Epub 2012 Jan 14.
citation: Yao Y, Zheng L, Zhang S, He DS, Zhang K, Tang M, Chen K, Pu J, Wang F, Chen X. Stepwise linear approach to catheter ablation of atrial fibrillation. Heart Rhythm. 2007 Dec;4(12):1497-504. doi: 10.1016/j.hrthm.2007.07.028. Epub 2007 Aug 11.
citation: Wu L, Yao Y, Zheng L, Zhang K, Zhang S. Long-term follow-up of pure linear ablation for persistent atrial fibrillation without circumferential pulmonary vein isolation. J Cardiovasc Electrophysiol. 2014 May;25(5):471-476. doi: 10.1111/jce.12360. Epub 2014 Jan 24.