Atrial FibrillationSTABLE-SR_IINCT03448562
CPVI Alone Versus. CPVI Plus Electrophysiological Substrate Ablation in the LA During SR for the Treatment of Non-PAF
A study testing CPVI and STABLE-SR in people with Atrial Fibrillation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in patients with non-paroxysmal AF: CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm (STABLE-SR) and CPVI alone. 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?
- CPVI and STABLE-SR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 30 Sep 2020
- 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 age is 18-80 years;
- Patients with non-paroxysmal AF; non-paroxysmal AF will be defined as a sustained episode lasting > 7 days;
- Patients can sign the written informed consent for the study;
- Patients can endure the required follow-up.
Who cannot join
- Patients with previous radiofrequency ablation;
- Patients with PLT count less than 80×109/L, or with contraindications to systemic anticoagulation with heparin or Coumadin or a direct thrombin inhibitor;
- Patients with left atrial size ≥ 55 mm (2D echocardiography, parasternal long-axis view);
- Patients with thromboemboli in LA (TEE or MSCT);
- Patients with severe structural cardiac disease (medium or severe mitral regurgitation, DCM, HCM, or other severe valvular heart diseases);
- Patients with abnormal thyroid function;
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- Patients with severe liver or renal dysfunction (AST or ALT > 3-fold of upper limit value; the SCr > 3.5 mg/dl or Ccr < 30 ml/min);
- Previous surgery history in last 3 months;
- Patients with life expectancy < 12 months; and
- Patients who are 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, 210000
Gang Yang, MD, 86-18601406982, yanggang201301@163.com
Chen minglong, MD
About this study
Official title: Circumferential Pulmonary Vein Isolation Alone Versus. Circumferential Pulmonary Vein Isolation Plus Electrophysiological Substrate Ablation in the Left Atrium During Sinus Rhythm for the Treatment of Non-paroxysmal Atrial Fibrillation
The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in patients with non-paroxysmal AF: CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm (STABLE-SR) and CPVI alone.
Read the detailed description
BACKGROUND: Atrial fibrillation (AF) is the most common cardiac rhythm disorder, which affects patients' morbidity and mortality. AF ablation has emerged as a promising treatment strategy, offering the possibility of a durable treatment. Currently, there is no general agreement regarding NPAF ablation strategy. Obviously, pulmonary vein isolation is the corner stone for all types of AF ablation. The consensus is that CPVI alone is insufficient for NPAF ablation. However, the recent clinical trials did not show the additional benefits of other substrate modification strategies. Furthermore, the widely used cryo-ablation dilutes the concept that NPAF needs additional substrate modification to further improve the clinical outcome. It seems that CPVI only as the optimal strategy is more commonly accepted for NPAF patients in most of the centers. Based on the results from our pilot study and STABLE-SR trial, we believe that fibrotic substrate modification beyond CPVI is very promising for NPAF ablation, but its superiority over CPVI alone needs a large scaled randomized trial to prove.
AIM OF THE STUDY: The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in patients with non-paroxysmal AF: CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm (STABLE-SR) and CPVI alone. The primary endpoint is freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each episode lasts > 30 seconds. The secondary endpoint are incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death; procedure time; fluoroscopy time (including the total fluoroscopy time, during CPVI and after CPVI); the occurrence of the conversion from AF to AT, and its relationship with long-term outcome; the relationship between acute termination of AF and long term outcome.
STUDY DESIGN: This is a randomized, prospective, parallel, single-blind multicenter design. The enrollment target for this investigation is 300 patients. Patients are randomized in a 1:1 fashion into one of the investigation arms: CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm (STABLE-SR) and CPVI alone. Follow-up for these patients includes visits at 3 m, 6 m, 9 m, 12 m.
- Conditions
- Atrial Fibrillation
- Being tested
- CPVI, STABLE-SR
- Keywords
- Atrial Fibrillation, Pulmonary Vein Isolation, Catheter Ablation, Substrate Modification
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPVIProcedure or surgery
ablate around the pulmonary vein orifice
STABLE-SRProcedure or surgery
homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm (STABLE-SR) Receives: Procedure: CPVI; Procedure: STABLE-SR |
| Control Group | Active comparator | CPVI alone Receives: Procedure: CPVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs)
Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each episode lasts > 30 seconds.
Measured: at least 12 months follow up
Secondary outcomes (5)
Incidence of peri-procedural complications
stroke, PV stenosis, cardiac perforation, esophageal injury and death
Measured: 1 week after patient enrollment
Procedure time
time that the patient spend in the procedure room
Measured: 1 week after patient enrollment
Fluoroscopy time
the total fluoroscopy time, during CPVI and after CPVI
Measured: 1 week after patient enrollment
Occurrence of the conversion from AF to AT
the occurrence of the conversion from AF to AT, and its relationship with long-term outcome
Measured: at least 12 months follow up
Relationship between acute termination of AF and long term outcome
the relationship between acute termination of AF and long term outcome
Measured: at least 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 Apr 2018
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (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.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Fudan University, First Affiliated Hospital of Wannan Medical College, The Second Hospital of Hebei Medical University, General Hospital of Shenyang Military Region, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital, Zhongda Hospital, University of Pennsylvania, Southlake Health, German Heart Institute, Asklepios Kliniken Hamburg GmbH, National University Hospital, Singapore, Royal Brompton & Harefield NHS Foundation Trust, National Heart Centre Singapore, Semmelweis University Heart and Vascular Center, University of Minnesota
- Responsible party
- Principal investigator, Minglong Chen, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448562
- Sponsor's protocol ID
- 2017-SR-322
- Acronym
- STABLE-SR_II
- Status last verified
- Feb 2020
- First submitted
- 27 Dec 2017
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang H, Chen N, Bian Q, Yuan M, Yang G, Shen Y, Chen H, Ju W, Li M, Gu K, Wu N, Liu H, Chen M. Persistent atrial fibrillation with left atrial low-voltage area: who benefit from additional modification? Europace. 2025 May 7;27(5):euaf095. doi: 10.1093/europace/euaf095.
PubMed 40327545Yang G, Zheng L, Jiang C, Fan J, Liu X, Zhan X, Li J, Wang L, Yang H, Zhu W, Du H, Ma G, Ma W, Kojodjojo P, Chen M; STABLE-SR-II Investigators. Circumferential Pulmonary Vein Isolation Plus Low-Voltage Area Modification in Persistent Atrial Fibrillation: The STABLE-SR-II Trial. JACC Clin Electrophysiol. 2022 Jul;8(7):882-891. doi: 10.1016/j.jacep.2022.03.012. Epub 2022 Apr 27.
PubMed 35863814
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circumferential Pulmonary Vein Isolation Alone Versus. Circumferential Pulmonary Vein Isolation Plus Electrophysiological Substrate Ablation in the Left Atrium During Sinus Rhythm for the Treatment of Non-paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03448562
- Acronym / sponsor ID
- STABLE-SR_II / 2017-SR-322
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Pulmonary Vein Isolation, Catheter Ablation, Substrate Modification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Fudan University, First Affiliated Hospital of Wannan Medical College, The Second Hospital of Hebei Medical University, General Hospital of Shenyang Military Region, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital, Zhongda Hospital, University of Pennsylvania, Southlake Health, German Heart Institute, Asklepios Kliniken Hamburg GmbH, National University Hospital, Singapore, Royal Brompton & Harefield NHS Foundation Trust, National Heart Centre Singapore, Semmelweis University Heart and Vascular Center, University of Minnesota
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 28 Feb 2018 (actual)
- 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.
The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in patients with non-paroxysmal AF: CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm (STABLE-SR) and CPVI alone.
Detailed description
BACKGROUND: Atrial fibrillation (AF) is the most common cardiac rhythm disorder, which affects patients' morbidity and mortality. AF ablation has emerged as a promising treatment strategy, offering the possibility of a durable treatment. Currently, there is no general agreement regarding NPAF ablation strategy. Obviously, pulmonary vein isolation is the corner stone for all types of AF ablation. The consensus is that CPVI alone is insufficient for NPAF ablation. However, the recent clinical trials did not show the additional benefits of other substrate modification strategies. Furthermore, the widely used cryo-ablation dilutes the concept that NPAF needs additional substrate modification to further improve the clinical outcome. It seems that CPVI only as the optimal strategy is more commonly accepted for NPAF patients in most of the centers. Based on the results from our pilot study and STABLE-SR trial, we believe that fibrotic substrate modification beyond CPVI is very promising for NPAF ablation, but its superiority over CPVI alone needs a large scaled randomized trial to prove.
AIM OF THE STUDY: The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in patients with non-paroxysmal AF: CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm (STABLE-SR) and CPVI alone. The primary endpoint is freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each episode lasts > 30 seconds. The secondary endpoint are incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death; procedure time; fluoroscopy time (including the total fluoroscopy time, during CPVI and after CPVI); the occurrence of the conversion from AF to AT, and its relationship with long-term outcome; the relationship between acute termination of AF and long term outcome.
STUDY DESIGN: This is a randomized, prospective, parallel, single-blind multicenter design. The enrollment target for this investigation is 300 patients. Patients are randomized in a 1:1 fashion into one of the investigation arms: CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm (STABLE-SR) and CPVI alone. Follow-up for these patients includes visits at 3 m, 6 m, 9 m, 12 m.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: CPVI, Procedure: STABLE-SRCPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm (STABLE-SR) |
| Control Group | Active comparator | Procedure: CPVICPVI alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients age is 18-80 years;
- Patients with non-paroxysmal AF; non-paroxysmal AF will be defined as a sustained episode lasting > 7 days;
- Patients can sign the written informed consent for the study;
- Patients can endure the required follow-up.
Key exclusion criteria (10 listed)
- Patients with previous radiofrequency ablation;
- Patients with PLT count less than 80×109/L, or with contraindications to systemic anticoagulation with heparin or Coumadin or a direct thrombin inhibitor;
- Patients with left atrial size ≥ 55 mm (2D echocardiography, parasternal long-axis view);
- Patients with thromboemboli in LA (TEE or MSCT);
- Patients with severe structural cardiac disease (medium or severe mitral regurgitation, DCM, HCM, or other severe valvular heart diseases);
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 |
|---|---|---|
| CPVIablate around the pulmonary vein orifice | Procedure or surgery | Control Group, Study Group |
| STABLE-SRhomogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm | Procedure or surgery | Study Group |
Primary outcome
Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs)
Time frame: at least 12 months follow up
Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each episode lasts > 30 seconds.
5 secondary outcomes
Incidence of peri-procedural complications
Time frame: 1 week after patient enrollment
Procedure time
Time frame: 1 week after patient enrollment
Fluoroscopy time
Time frame: 1 week after patient enrollment
Occurrence of the conversion from AF to AT
Time frame: at least 12 months follow up
Relationship between acute termination of AF and long term outcome
Time frame: at least 12 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Derived from this study: PubMed 40327545Zhang H, Chen N, Bian Q, Yuan M, Yang G, Shen Y, Chen H, Ju W, Li M, Gu K, Wu N, Liu H, Chen M. Persistent atrial fibrillation with left atrial low-voltage area: who benefit from additional modification? Europace. 2025 May 7;27(5):euaf095. doi: 10.1093/europace/euaf095.
- Derived from this study: PubMed 35863814Yang G, Zheng L, Jiang C, Fan J, Liu X, Zhan X, Li J, Wang L, Yang H, Zhu W, Du H, Ma G, Ma W, Kojodjojo P, Chen M; STABLE-SR-II Investigators. Circumferential Pulmonary Vein Isolation Plus Low-Voltage Area Modification in Persistent Atrial Fibrillation: The STABLE-SR-II Trial. JACC Clin Electrophysiol. 2022 Jul;8(7):882-891. doi: 10.1016/j.jacep.2022.03.012. Epub 2022 Apr 27.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPVI and STABLE-SR 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 4 inclusion and 10 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 11 Feb 2020. 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 Gang Yang, MD (86-2568303115, yanggang201301@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 ATs with or without antiarrhythmic drugs (AADs) (time frame: at least 12 months follow up). 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 NCT03448562, 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 11 Feb 2020.