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

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

Tracking Information

• First Submitted Date: December 15, 2012
• First Posted Date: January 4, 2013
• Last Update Posted Date: June 25, 2013
• Study Start Date: June 2013
• Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Atrial Fibrillation

Intervention

Procedure: Ablation

electrophysiology substrate mapping is the critical difference between both groups

Study Arms

• 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 *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 3, 2013): 220
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2015
• Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01761188
• Other Study ID Numbers: 201201
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Gang Yang, The First Affiliated Hospital with Nanjing Medical University
• Study Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Abbott Medical Devices

Investigators

• 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