Atrial FibrillationSTABLE-SRNCT01761188
the Study of STABLE_SR for Persistent Atrial Fibrillation
A study testing Ablation in people with Atrial Fibrillation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Minglong Chen, M.D., 008613809000791, chenminglong2001@163.com
Minglong Chen, M.D.
About this study
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
- 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
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Ablation
- Keywords
- Persistent Atrial fibrillation;LA substrate;ablation;voltage mapping
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
electrophysiology substrate mapping is the critical difference between both groups
| Study group | Role | What they receive |
|---|---|---|
| STABLE-SR | Experimental | CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm ( STABLE-SR) Receives: Procedure: Ablation |
| Control Group | Experimental | conventional stepwise ablation approach for persistent AF(CPVI + Lines +CFE) . Receives: Procedure: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after a single-ablation procedure
Secondary outcomes (3)
total procedure time
time from puncture to the end
Measured: 1 year
fluoroscopy time
total fluoroscopy time
Measured: 1 year
complications
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, Gang Yang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Minglong Chen, M.D., Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761188
- Sponsor's protocol ID
- 201201
- Acronym
- STABLE-SR
- Status last verified
- Jun 2013
- First submitted
- 15 Dec 2012
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 31937118Yang 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.
PubMed 29141843
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01761188
- Acronym / sponsor ID
- STABLE-SR / 201201
- Conditions
- Atrial Fibrillation
- Keywords
- Persistent Atrial fibrillation;LA substrate;ablation;voltage mapping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STABLE-SR | Experimental | Procedure: AblationCPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm ( STABLE-SR) |
| Control Group | Experimental | Procedure: Ablationconventional stepwise ablation approach for persistent AF(CPVI + Lines +CFE) . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablationelectrophysiology substrate mapping is the critical difference between both groups | Procedure or surgery | Control Group, STABLE-SR |
Primary outcome
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.
3 secondary outcomes
total procedure time
Time frame: 1 year
fluoroscopy time
Time frame: 1 year
complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2013.
- Derived from this study: PubMed 31937118Yu 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.
- Derived from this study: PubMed 29141843Yang 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.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minglong Chen, M.D. principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation in people with Atrial Fibrillation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minglong Chen, M.D. (008613809000791, chenminglong2001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from AF and/or atrial tachyarrhythmias (ATs) off antiarrhythmic drugs (AADs). (time frame: 1 year after a single-ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01761188, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2013.