CPVI Alone Versus. CPVI Plus Electrophysiological Substrate Ablation in the LA During SR for the Treatment of Non-PAF (STABLE-SR_II)
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| ClinicalTrials.gov Identifier: NCT03448562 |
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Recruitment Status : Unknown
Verified February 2020 by Minglong Chen, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was: Recruiting
First Posted : February 28, 2018
Last Update Posted : February 11, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation | Procedure: CPVI Procedure: STABLE-SR | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | April 1, 2018 |
| Estimated Primary Completion Date : | September 30, 2020 |
| Estimated Study Completion Date : | September 30, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Study Group
CPVI plus electrophysiologic substrate ablation in the left atrium during sinus rhythm (STABLE-SR)
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Procedure: CPVI
ablate around the pulmonary vein orifice Procedure: STABLE-SR homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm |
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Active Comparator: Control Group
CPVI alone
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Procedure: CPVI
ablate around the pulmonary vein orifice |
- 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.
- Incidence of peri-procedural complications [ Time Frame: 1 week after patient enrollment ]stroke, PV stenosis, cardiac perforation, esophageal injury and death
- Procedure time [ Time Frame: 1 week after patient enrollment ]time that the patient spend in the procedure room
- Fluoroscopy time [ Time Frame: 1 week after patient enrollment ]the total fluoroscopy time, during CPVI and after CPVI
- Occurrence of the conversion from AF to AT [ Time Frame: at least 12 months follow up ]the occurrence of the conversion from AF to AT, and its relationship with long-term outcome
- Relationship between acute termination of AF and long term outcome [ Time Frame: at least 12 months follow up ]the relationship between acute termination of AF and long term outcome
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448562
| Contact: Gang Yang, MD | 86-2568303115 | yanggang201301@163.com |
| China, Jiangsu | |
| The First Affiliated Hospital of Nanjing Medical University | Recruiting |
| Nanjing, Jiangsu, China, 210000 | |
| Contact: Gang Yang, MD 86-18601406982 yanggang201301@163.com | |
| Principal Investigator: Chen minglong, MD | |
| Responsible Party: | Minglong Chen, Deputy Director of the Department of Cardiology, The First Affiliated Hospital with Nanjing Medical University |
| ClinicalTrials.gov Identifier: | NCT03448562 |
| Other Study ID Numbers: |
2017-SR-322 |
| First Posted: | February 28, 2018 Key Record Dates |
| Last Update Posted: | February 11, 2020 |
| Last Verified: | February 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Atrial Fibrillation Pulmonary Vein Isolation Catheter Ablation Substrate Modification |
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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |