Application Value of Whole-procedure Optimization for Catheter Ablation of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Application Value of Whole-procedure Optimization for Catheter Ablation of Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145906
• Other study ID #: HenanPPH Cardiology
• Status: Recruiting
• Start date: December 26, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: March 2024
• Source: Henan Provincial People's Hospital
• Contact: Yingjie Chu
• Phone: +8613027736160
• Email: hnqbdsl[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Radiofrequency catheter ablation for the first time

• AF rhythm recorded by ECG

Exclusion Criteria:

• Thrombosis in left atrium

• Left ventricular ejection fraction of < 35%

• Abnormal thyroid function

• Previous history of AF radiofrequency ablation and CABG

• Left atrium diameter of > 65 mm or the volume of > 200 ml

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Pulmonary vein isolation plus superior vena cava isolation
Pulmonary vein isolation plus superior vena cava isolation
• 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

Locations

Country	Name	City	State
China	Department of Cardiology, Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

Inoue K, Hikoso S, Masuda M, Furukawa Y, Hirata A, Egami Y, Watanabe T, Minamiguchi H, Miyoshi M, Tanaka N, Oka T, Okada M, Kanda T, Matsuda Y, Kawasaki M, Hayashi K, Kitamura T, Dohi T, Sunaga A, Mizuno H, Nakatani D, Sakata Y; OCVC Arrhythmia Investigat — View Citation

Mark DB, Anstrom KJ, Sheng S, Piccini JP, Baloch KN, Monahan KH, Daniels MR, Bahnson TD, Poole JE, Rosenberg Y, Lee KL, Packer DL; CABANA Investigators. Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillat — View Citation

Mont L, Bisbal F, Hernandez-Madrid A, Perez-Castellano N, Vinolas X, Arenal A, Arribas F, Fernandez-Lozano I, Bodegas A, Cobos A, Matia R, Perez-Villacastin J, Guerra JM, Avila P, Lopez-Gil M, Castro V, Arana JI, Brugada J; SARA investigators. Catheter ab — View Citation

Shah S, Barakat AF, Saliba WI, Abdur Rehman K, Tarakji KG, Rickard J, Bassiouny M, Baranowski B, Tchou P, Bhargava M, Chung M, Dresing T, Callahan T, Cantillon D, Kanj M, Lindsay BD, Wazni OM, Hussein AA. Recurrent Atrial Fibrillation After Initial Long-T — View Citation

Yu HT, Shim J, Park J, Kim IS, Kim TH, Uhm JS, Joung B, Lee MH, Kim YH, Pak HN. Pulmonary Vein Isolation Alone Versus Additional Linear Ablation in Patients With Persistent Atrial Fibrillation Converted to Paroxysmal Type With Antiarrhythmic Drug Therapy: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF recurrence	Any symptomatic or asymptomatic atrial arrhythmia lasting more than 30 seconds after a 3-month blanking period	12 months
Secondary	initial block rate	initial block rate of pulmonary veins isolation, superior vena cava isolation and additional ablation lines	intraoperation