Paroxysmal Atrial FibrillationSTABLE-SR-IIINCT03462628
Additional Low Voltage Area Ablation in Older Patients With Paroxysmal Atrial Fibrillation
A study testing CPVI plus low-voltage substrate modification and CPVI alone in people with Paroxysmal 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 older patients with paroxysmal AF: Pulmonary vein isolation alone versus additional low-voltage substrate modification during sinus rhythm Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- CPVI plus low-voltage substrate modification and CPVI alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2018to 17 Aug 2021
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients age is 65-80 years;
- Patients with paroxysmal AF;
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Additional Low Voltage Area Ablation in Older Patients With Paroxysmal Atrial Fibrillation: a Randomized Control Trial of STABLE-SR-III
The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in older patients with paroxysmal AF: Pulmonary vein isolation alone versus additional low-voltage substrate modification during sinus rhythm
Read the detailed description
BACKGROUND: Atrial fibrillation (AF) is the most common cardiac rhythm disorder. Catheter ablation to the pulmonary veins isolation (PVI) electrically from the left atrium (LA) has been shown to be an effective treatment for paroxysmal AF (PAF). The consensus is that PVI alone is the main strategy for PAF ablation. Based on the results from our pilot study and STABLE-SR trial, that low-voltage modification beyond CPVI is very promising for persistent AF ablation. Whether the low voltage area modification combined with PVI improves outcomes is unclear in older patients with PAF.
AIM OF THE STUDY: The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in older patients with PAF: PVI alone versus additional low-voltage substrate modification during sinus rhythm. The primary endpoint is freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12 months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each atrial tachyarrhythmia episode lasts > 30 seconds monitored by ECG, 24-Holter or 7 days-Holter was defined as recurrence. The secondary endpoint are incidence of periprocedural 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 scar distribution and the relationship of success rate in older PAF patients.
STUDY DESIGN: This is a randomized, prospective, parallel, single-blind multicenter design. The expected freedom from atrial fibrillation in older patients after one ablation procedure was 75% for PVI. Previous study did not include a group assigned to isolation plus additional low-voltage substrate modification during sinus rhythm, so freedom form AF for this procedure was estimated from the literature at 85%. A log-rank test was used for sample-size calculation. To test whether the isolation plus low-voltage substrate modification was superior to isolation only. Then the 369 patients were needed, with a randomization ratio of 1:1, for the study to have a power of 90% at a two-sided alpha level of 0.05. Assuming a dropout rate of 15%, we need 434 patients. Patients are randomized in a 1:1 fashion into one of the investigation arms: CPVI plus low-voltage substrate modification in the left atrium during SR and CPVI alone. Follow-up for these patients includes visits at 3 m, 6 m, 9 m, 12 m.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- CPVI plus low-voltage substrate modification, CPVI alone
- Keywords
- substrate modification, pulmonary vein isolation, ablation, Paroxysmal Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPVI plus low-voltage substrate modificationProcedure or surgery
Also called CPVI plus additional low-voltage substrate modification
CPVI plus low-voltage substrate modification in the left atrium during SR
CPVI aloneProcedure or surgery
circumferential pulmonary vein isolation
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | PVI with additional low-voltage substrate modification Receives: Procedure: CPVI plus low-voltage substrate modification |
| Control Group | Active comparator | PVI only Receives: Procedure: CPVI alone |
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 (4)
Incidence of peri-procedural complications
stroke, cardiac perforation, and death
Measured: 1 week after patient enrollment
complications during the follow-up
PV stenosis, esophageal injury
Measured: 1month to 12 months
Procedure time
time that the patient spend in the procedure room
Measured: 1 week after patient enrollment
Fluoroscopy time
the total fluoroscopy time, during PVI alone or PVI plus low-voltage substrate modification
Measured: 1 week after patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start24 Apr 2018
- Primary completion3 Aug 2020
- Study completion17 Aug 2021
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 Paroxysmal 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
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University, First Affiliated Hospital of Wannan Medical College, Second Affiliated Hospital of Nantong University, Zhongda Hospital, The Third Affiliated Hospital of Soochow University, The Second Hospital of Hebei Medical University, The First Affiliated Hospital of Soochow University, Xuzhou Central Hospital, the Affiliated Xuzhou Hospital of Medical College of Southeast University, Air Force Military Medical University, China
- Responsible party
- Principal investigator, Minglong Chen, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Minglong Chen, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462628
- Sponsor's protocol ID
- 2015-SR-085
- Acronym
- STABLE-SR-III
- Status last verified
- Apr 2022
- First submitted
- 1 Mar 2018
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qi X, Chen H, Yang G, Liu H, Wang Z, Jiang X, Cui C, Cai C, Ju W, Chen M. Unipolar Voltage for Better Characterizing Left Atrium Substrates: Comparing the Predictive Efficacy for Recurrence Post Atrial Fibrillation Ablation in a Post Hoc Analysis of STABLE-SR-III Trial. J Cardiovasc Electrophysiol. 2025 Jan;36(1):149-156. doi: 10.1111/jce.16490. Epub 2024 Nov 7.
PubMed 39511789Chen H, Li C, Han B, Xiao F, Yi F, Wei Y, Jiang C, Zou C, Shi L, Ma W, Wang W, Wang Y, Du H, Chen L, Chen M; STABLE-SR-III Investigators. Circumferential Pulmonary Vein Isolation With vs Without Additional Low-Voltage-Area Ablation in Older Patients With Paroxysmal Atrial Fibrillation: A Randomized Clinical Trial. JAMA Cardiol. 2023 Aug 1;8(8):765-772. doi: 10.1001/jamacardio.2023.1749.
PubMed 37378966
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Low Voltage Area Ablation in Older Patients With Paroxysmal Atrial Fibrillation: a Randomized Control Trial of STABLE-SR-III
- ClinicalTrials.gov ID
- NCT03462628
- Acronym / sponsor ID
- STABLE-SR-III / 2015-SR-085
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- substrate modification, pulmonary vein isolation, ablation, Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University, First Affiliated Hospital of Wannan Medical College, Second Affiliated Hospital of Nantong University, Zhongda Hospital, The Third Affiliated Hospital of Soochow University, The Second Hospital of Hebei Medical University, The First Affiliated Hospital of Soochow University, Xuzhou Central Hospital, the Affiliated Xuzhou Hospital of Medical College of Southeast University, Air Force Military Medical University, China
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 12 Mar 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 older patients with paroxysmal AF: Pulmonary vein isolation alone versus additional low-voltage substrate modification during sinus rhythm
Detailed description
BACKGROUND: Atrial fibrillation (AF) is the most common cardiac rhythm disorder. Catheter ablation to the pulmonary veins isolation (PVI) electrically from the left atrium (LA) has been shown to be an effective treatment for paroxysmal AF (PAF). The consensus is that PVI alone is the main strategy for PAF ablation. Based on the results from our pilot study and STABLE-SR trial, that low-voltage modification beyond CPVI is very promising for persistent AF ablation. Whether the low voltage area modification combined with PVI improves outcomes is unclear in older patients with PAF.
AIM OF THE STUDY: The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in older patients with PAF: PVI alone versus additional low-voltage substrate modification during sinus rhythm. The primary endpoint is freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12 months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each atrial tachyarrhythmia episode lasts > 30 seconds monitored by ECG, 24-Holter or 7 days-Holter was defined as recurrence. The secondary endpoint are incidence of periprocedural 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 scar distribution and the relationship of success rate in older PAF patients.
STUDY DESIGN: This is a randomized, prospective, parallel, single-blind multicenter design. The expected freedom from atrial fibrillation in older patients after one ablation procedure was 75% for PVI. Previous study did not include a group assigned to isolation plus additional low-voltage substrate modification during sinus rhythm, so freedom form AF for this procedure was estimated from the literature at 85%. A log-rank test was used for sample-size calculation. To test whether the isolation plus low-voltage substrate modification was superior to isolation only. Then the 369 patients were needed, with a randomization ratio of 1:1, for the study to have a power of 90% at a two-sided alpha level of 0.05. Assuming a dropout rate of 15%, we need 434 patients. Patients are randomized in a 1:1 fashion into one of the investigation arms: CPVI plus low-voltage substrate modification in the left atrium during 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
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: CPVI plus low-voltage substrate modificationPVI with additional low-voltage substrate modification |
| Control Group | Active comparator | Procedure: CPVI alonePVI only |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients age is 65-80 years;
- Patients with paroxysmal AF;
- Patients can sign the written informed consent for the study;
- Patients can endure the required follow-up.
Key exclusion criteria (9 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 |
|---|---|---|
| CPVI plus low-voltage substrate modificationAlso: CPVI plus additional low-voltage substrate modificationCPVI plus low-voltage substrate modification in the left atrium during SR | Procedure or surgery | Study Group |
| CPVI alonecircumferential pulmonary vein isolation | Procedure or surgery | Control 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.
4 secondary outcomes
Incidence of peri-procedural complications
Time frame: 1 week after patient enrollment
complications during the follow-up
Time frame: 1month to 12 months
Procedure time
Time frame: 1 week after patient enrollment
Fluoroscopy time
Time frame: 1 week after patient enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Derived from this study: PubMed 39511789Qi X, Chen H, Yang G, Liu H, Wang Z, Jiang X, Cui C, Cai C, Ju W, Chen M. Unipolar Voltage for Better Characterizing Left Atrium Substrates: Comparing the Predictive Efficacy for Recurrence Post Atrial Fibrillation Ablation in a Post Hoc Analysis of STABLE-SR-III Trial. J Cardiovasc Electrophysiol. 2025 Jan;36(1):149-156. doi: 10.1111/jce.16490. Epub 2024 Nov 7.
- Derived from this study: PubMed 37378966Chen H, Li C, Han B, Xiao F, Yi F, Wei Y, Jiang C, Zou C, Shi L, Ma W, Wang W, Wang Y, Du H, Chen L, Chen M; STABLE-SR-III Investigators. Circumferential Pulmonary Vein Isolation With vs Without Additional Low-Voltage-Area Ablation in Older Patients With Paroxysmal Atrial Fibrillation: A Randomized Clinical Trial. JAMA Cardiol. 2023 Aug 1;8(8):765-772. doi: 10.1001/jamacardio.2023.1749.
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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.
Minglong Chen 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 CPVI plus low-voltage substrate modification and CPVI alone in people with Paroxysmal 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 9 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: finished, as of the sponsor's last update on 4 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT03462628, 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 4 May 2022.