the Study of STABLE_SR for Persistent Atrial Fibrillation
STABLE-SR
The Study of CPVI Plus Electrophysiological Substrate Ablation in the Left Atrium During Sinus Rhythm (STABLE-SR) for the Treatment of Persistent Atrial Fibrillation
1 other identifier
interventional
220
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Jun 2013
Shorter than P25 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2012
CompletedFirst Posted
Study publicly available on registry
January 4, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJune 25, 2013
June 1, 2013
1.1 years
December 15, 2012
June 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freedom from AF and/or atrial tachyarrhythmias (ATs) off antiarrhythmic drugs (AADs).
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.
1 year after a single-ablation procedure
Secondary Outcomes (3)
total procedure time
1 year
fluoroscopy time
1 year
complications
1 year
Study Arms (2)
STABLE-SR
EXPERIMENTALCPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm ( STABLE-SR)
Control Group
EXPERIMENTALconventional stepwise ablation approach for persistent AF(CPVI + Lines +CFE) .
Interventions
electrophysiology substrate mapping is the critical difference between both groups
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Related Publications (2)
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.
PMID: 31937118DERIVEDYang 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.
PMID: 29141843DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Minglong Chen, M.D.
The First Affiliated Hospital with Nanjing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor of Cardiology Department
Study Record Dates
First Submitted
December 15, 2012
First Posted
January 4, 2013
Study Start
June 1, 2013
Primary Completion
July 1, 2014
Study Completion
January 1, 2015
Last Updated
June 25, 2013
Record last verified: 2013-06