Clinical trial NCT01761188: the Study of STABLE_SR for Persistent Atrial Fibrillation
Official title: The Study of CPVI Plus Electrophysiological Substrate Ablation in the Left Atrium During Sinus Rhythm (STABLE-SR) for the Treatment of Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Persistent Atrial fibrillation;LA substrate;ablation;voltage mapping
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2013-01-04
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Background:the ablation outcomes for the treatment of persistent atrial fibrillation are not as satisfactory as paroxsymal AF. The successful rate ranges from 30%-55%. We found a new novel strategy for the modification of LA substrate during sinus rhythm based on our pilot study.
* Hypothesis: our new method may be more effective than conventional strategy.
* Objectives:The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in patients with persistent AF:Study Group: CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm ( STABLE-SR);Control Group: conventional stepwise approach for persistent AF(CPVI + Lines +CFE) .The secondary objectives of this investigation are to evaluate and compare the safety and procedural characteristics of both groups.
* Sample size: 220
* Time line: 2013 Q1-2014 Q2

Detailed description: what's is STABLE-SR approach? In our center, the LA substrate mapping was performed in patients with paroxysmal AF and persistent AF during sinus rhythm, particularly 20 normal subjects as control group as well. Our study showed that along with the duration of AF the average voltage of LA deceased and the area of low voltage zone increased. The whole activation time of entire LA would be longer. More complex fractionated electrograms was found in LA. Importantly, we identified the low voltage zone (voltage range: 0.1-0.4mV) and the transitional zone (voltage range: 0.4-1.3mV) in which most of complex fractionated electrograms located. Based on our findings a new novel ablation strategy has emerged, which is modification of LA substrate during sinus rhythm (CPVI+STABLE-SR). Our sequential protocol included 5 steps. First CPVI should be completed followed by CTI ablation to be blocked. Then if AF rhythm maintained cardioversion would be taken. High density mapping of LA substrate would be done during sinus rhythm to identify the low voltage zone and transitional zone. Linear ablation or/and spot ablation should be designed according to the mapping results. Finally bidirectional conduction block should be demonstrated for all the linear lesion and all pulmonary veins would be checked for isolation.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a first-time ablation procedure for AF;
* Patients with persistent or long-lasting AF; Persistent AF will be defined as a sustained episode lasting \> 7 days and less than 1 years; Long-lasting persistent AF will be more than 1 year and less than 5 years.
* Patients must be willing and able to comply with all peri-ablation and follow-up requirements.
* Patients with atrial fibrillation will to accept the procedure of ablation.
* Patients signed the written informed consent for the study.
* Patients can endure the required follow up.

Exclusion Criteria:

* Patients with paroxysmal AF; Paroxysmal AF will be defined as a sustained episode lasting \< 7days.
* Patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor.
* Patients with thromboemboli in LAA.
* Patients with left atrial size ≥ 55 mm (2D echocardiography, parasternal long-axis view).
* Patients allergic for contrast or iodine.
* Patients with the SCr \>3.5mg/dl or Ccr \< 30 ml/min
* Patients with life expectancy \< 12 months
* Patients who are in the period of pregnant

Primary outcomes:
measure: Freedom from AF and/or atrial tachyarrhythmias (ATs) off antiarrhythmic drugs (AADs).
timeFrame: 1 year after a single-ablation procedure
Secondary outcomes:
measure: total procedure time
timeFrame: 1 year
measure: fluoroscopy time
timeFrame: 1 year
measure: complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Minglong Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu Y, Wang X, Li X, Zhou X, Liao S, Yang W, Yu J, Zhang F, Ju W, Chen H, Yang G, Li M, Gu K, Tang L, Xu Y, Chan JY, Kojodjojo P, Cao K, Fan J, Yang B, Chen M. Higher Incidence of Asymptomatic Cerebral Emboli After Atrial Fibrillation Ablation Found With High-Resolution Diffusion-Weighted Magnetic Resonance Imaging. Circ Arrhythm Electrophysiol. 2020 Jan;13(1):e007548. doi: 10.1161/CIRCEP.119.007548. Epub 2020 Jan 14.
citation: Yang B, Jiang C, Lin Y, Yang G, Chu H, Cai H, Lu F, Zhan X, Xu J, Wang X, Ching CK, Singh B, Kim YH, Chen M; STABLE-SR Investigators*. STABLE-SR (Electrophysiological Substrate Ablation in the Left Atrium During Sinus Rhythm) for the Treatment of Nonparoxysmal Atrial Fibrillation: A Prospective, Multicenter Randomized Clinical Trial. Circ Arrhythm Electrophysiol. 2017 Nov;10(11):e005405. doi: 10.1161/CIRCEP.117.005405.