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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:
Abbott Medical Devices
Information provided by (Responsible Party):
Gang Yang, The First Affiliated Hospital with Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE December 15, 2012
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date June 25, 2013
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE the Study of STABLE_SR for Persistent Atrial Fibrillation
Official Title  ICMJE The Study of CPVI Plus Electrophysiological Substrate Ablation in the Left Atrium During Sinus Rhythm (STABLE-SR) for the Treatment of Persistent Atrial Fibrillation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Procedure: Ablation
electrophysiology substrate mapping is the critical difference between both groups
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 3, 2013)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2015
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761188
Other Study ID Numbers  ICMJE 201201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gang Yang, The First Affiliated Hospital with Nanjing Medical University
Study Sponsor  ICMJE The First Affiliated Hospital with Nanjing Medical University
Collaborators  ICMJE Abbott Medical Devices
Investigators  ICMJE
Principal Investigator: Minglong Chen, M.D. The First Affiliated Hospital with Nanjing Medical University
PRS Account The First Affiliated Hospital with Nanjing Medical University
Verification Date June 2013

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