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the Study of STABLE_SR for Persistent Atrial Fibrillation (STABLE-SR)

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ClinicalTrials.gov Identifier: NCT01761188
Recruitment Status : Unknown
Verified June 2013 by Gang Yang, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : January 4, 2013
Last Update Posted : June 25, 2013
Sponsor:
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
Gang Yang, The First Affiliated Hospital with Nanjing Medical University

December 15, 2012
January 4, 2013
June 25, 2013
June 2013
July 2014   (Final data collection date for primary outcome measure)
Freedom from AF and/or atrial tachyarrhythmias (ATs) off antiarrhythmic drugs (AADs). [ Time Frame: 1 year after a single-ablation procedure ]
AF and/or AT occurring in the first 3 months after the ablation (blanking period) were censored.Beyond this, any symptomatic or asymptomatic AF or AT episode that lasted for more than 30 seconds was categorized as a recurrence.
Same as current
Complete list of historical versions of study NCT01761188 on ClinicalTrials.gov Archive Site
  • total procedure time [ Time Frame: 1 year ]
    time from puncture to the end
  • fluoroscopy time [ Time Frame: 1 year ]
    total fluoroscopy time
  • complications [ Time Frame: 1 year ]
    occurrence of serious adverse events that included death, pericardial effusion causing tamponade or requiring pericardiocentesis, cerebrovascular events, significant PV stenosis (symptomatic or asymptomatic ≤70% reduction in PV diameter in ≥1 veins), left atrial-esophageal fistula, diaphragmatic paralysis, and any vascular complication requiring transfusion or intervention
Same as current
Not Provided
Not Provided
 
the Study of STABLE_SR for Persistent Atrial Fibrillation
The Study of CPVI Plus Electrophysiological Substrate Ablation in the Left Atrium During Sinus Rhythm (STABLE-SR) for the Treatment of Persistent Atrial Fibrillation
  • 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
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Atrial Fibrillation
Procedure: Ablation
electrophysiology substrate mapping is the critical difference between both groups
  • Experimental: STABLE-SR
    CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm ( STABLE-SR)
    Intervention: Procedure: Ablation
  • Experimental: Control Group
    conventional stepwise ablation approach for persistent AF(CPVI + Lines +CFE) .
    Intervention: Procedure: Ablation
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). pii: e005405. doi: 10.1161/CIRCEP.117.005405.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
220
Same as current
January 2015
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01761188
201201
Yes
Not Provided
Not Provided
Gang Yang, The First Affiliated Hospital with Nanjing Medical University
The First Affiliated Hospital with Nanjing Medical University
St. Jude Medical
Principal Investigator: Minglong Chen, M.D. The First Affiliated Hospital with Nanjing Medical University
The First Affiliated Hospital with Nanjing Medical University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP