Evaluation of Optimized Strategies and Workflows for Catheter Ablation of Paroxysmal ＆ Persistent Atrial Fibrillation
Study Details
Study Description
Brief Summary
Clinical trials have demonstrated that performing catheter ablation for atrial fibrillation (AF) is a superior alternative to antiarrhythmic drugs for the maintenance of sinus rhythm, reduction of arrhythmia-related symptoms, and improvement of left ventricular ejection fraction, all while having a comparable safety profile. Therefore, catheter ablation has become the mainstream treatment for preventing AF recurrences. Nevertheless, despite its established efficacy, a significant number of AF recurrences following the initial ablation procedure can still occur due to factors such as pulmonary vein reconnections, or incomplete isolation. The success rate of single-procedure atrial arrhythmia-free survival particularly ranged from 40% to 66% in persistent AF ablation. However, The surgical Cox maze III procedure has been established to be an effective curative strategy for AF with an AF-free survival rate of more than 95%. The main reason is the difficulty of creating continuous, transmural, and durable lesions by catheter ablation, especially when the procedure is performed on some complex anatomical structures in which epicardial muscular bundles may serve as components of the reentrant circuits.
The durability of the conduction block is a crucial factor for long-term effective AF ablation since previous studies reported that the reconnected Pulmonary veins contributed to the atrial tachycardia recurrence after persistent AF ablation. In addition, it is possible that the inadequate lesions accidentally produce new arrhythmogenic substrates. Therefore, new and better techniques are always chosen to minimize the reconnection of Pulmonary vein isolation (PVI) and additional ablation. In recent years, to improve the clinical outcomes following the initial ablation procedure, various advancements in techniques and technologies have been introduced. These include the use of contact force-sensing catheters, an ablation index-guided high-power ablation strategy, steerable guiding sheaths, intracardiac echocardiography catheters, and the incorporation of more extensive ablation. However, there is no standardized workflow in place, which can limit the effectiveness of AF ablation when performed by physicians in different medical centers.
The investigators meticulously optimized every aspect of the catheter ablation process for AF, striving to enhance catheter operability and stability to generate continuous and transmural lesions akin to surgical intervention. For paroxysmal AF, the ablation strategy of PVI plus superior vena cava isolation is chosen while PVI, superior vena cava isolation, and linear ablation of linear ablations of the mitral isthmus, roofline and posterior wall line of the left atrium, and cavotricuspid isthmus (CTI) for persistent AF. Any symptomatic or asymptomatic atrial arrhythmia lasting more than 30 seconds was regarded as an AF recurrence after a 3-month blanking period. The primary outcome was defined as 12-month atrial arrhythmia-free survival. The secondary outcomes include the block rate of PVI, superior vena cava isolation, and all linear ablations.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Paroxysmal AF group AF that terminates spontaneously or with intervention within 7 days of onset |
Procedure: Pulmonary vein isolation plus superior vena cava isolation
Pulmonary vein isolation plus superior vena cava isolation
|
| Persistent AF group AF that is continuously sustained beyond 7 days, including episodes terminated by cardioversion (drugs or electrical cardioversion) after ≥7 days |
Procedure: PVI, superior vena cava isolation, and linear ablation of linear ablations of the mitral isthmus, roofline and posterior wall line of the left atrium, and cavotricuspid isthmus
PVI, superior vena cava isolation, and linear ablation of linear ablations of the mitral isthmus, roofline and posterior wall line of the left atrium, and cavotricuspid isthmus
|
Outcome Measures
Primary Outcome Measures
- AF recurrence [12 months]
Any symptomatic or asymptomatic atrial arrhythmia lasting more than 30 seconds after a 3-month blanking period
Secondary Outcome Measures
- initial block rate [intraoperation]
initial block rate of pulmonary veins isolation, superior vena cava isolation and additional ablation lines
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Radiofrequency catheter ablation for the first time
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Palpitation, chest tightness and other symptoms that can't be controlled by antiarrhythmic drugs
Exclusion Criteria:
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Thrombosis in left atrium
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Left ventricular ejection fraction of < 35%
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Abnormal thyroid function
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Previous history of AF radiofrequency ablation and CABG
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Severe valvular heart disease or postoperation prosthetic valve surgery
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Left atrium diameter of > 65 mm or the volume of > 200 ml
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Cardiology, Henan Provincial People's Hospital | Zhengzhou | Henan | China | 450000 |
Sponsors and Collaborators
- Henan Provincial People's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- El Haddad M, Taghji P, Phlips T, Wolf M, Demolder A, Choudhury R, Knecht S, Vandekerckhove Y, Tavernier R, Nakagawa H, Duytschaever M. Determinants of Acute and Late Pulmonary Vein Reconnection in Contact Force-Guided Pulmonary Vein Isolation: Identifying the Weakest Link in the Ablation Chain. Circ Arrhythm Electrophysiol. 2017 Apr;10(4):e004867. doi: 10.1161/CIRCEP.116.004867.
- Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL. Corrigendum to: 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Oct 21;42(40):4194. doi: 10.1093/eurheartj/ehab648. No abstract available.
- HenanPPH Cardiology