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
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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 | ||||
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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 |
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.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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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 |
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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 |
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Condition ICMJE | Atrial Fibrillation | |||
Intervention ICMJE | Procedure: Ablation
electrophysiology substrate mapping is the critical difference between both groups
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |