Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation

NACompletedINTERVENTIONAL
Enrollment

498

Participants

Timeline

Start Date

August 27, 2021

Primary Completion Date

July 18, 2024

Study Completion Date

July 18, 2024

Conditions
Persistent Atrial FibrillationCatheter Ablation
Interventions
PROCEDURE

upgraded '2C3L'

Patients randomized to the upgraded '2C3L' arm will first undergo EI-VOM, followed by the '2C3L' ablation step. The details include: (1). EI-VOM procedure: An 8.5-French-long sheath or a steerable long sheath is sent to the coronary sinus (CS) via the femoral vein. A JR4.0 catheter is inserted into the CS to identify the ostium of the VOM. Subsequently, a BMW wire supported by an OTW balloon catheter is advanced into the VOM. The balloon is inflated with 6 to 8 atm in the VOM. A selective venogram of the VOM is obtained by slowly injecting 1 mL of contrast medium. Then, ethanol is slowly injected into the VOM and selective venography of the VOM is repeated. (2) . After EI-VOM, radiofrequency ablation was performed to achieve bilateral pulmonary vein isolation and bidirectional block of mitral isthmus line, roof line, and cavotricuspid isthmus line. (3). Any organized AT observed during the procedure will be targeted as well.

PROCEDURE

pulmonary vein antral isolation

After reconstructing the left atrial geometry, PVI will be performed (the right PV antrum (PVA) will be ablated first, followed by the left PVA. ) in a wide area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished. The endpoint of the circumferential PVA ablation procedure is to achieve electrical bilateral PV isolation, that is, the PV potentials associated with atrial electrical activity cannot be recorded during sinus rhythm or CS pacing (entrance block). A waiting period of at least 20 min (after the last PV is isolated) will be used during which spontaneous PV reconnection will be related. , and tDemonstration of exit block (he by pacing in the PV cannot be and proving the absence of transmitted conduction to capture the atrium) may be performed but is not mandatory. Any organized AT observed during the procedure will be targeted as well.

Trial Locations (12)

100029

Beijing Anzhen Hospital, Beijing

150001

The First Affiliated Hospital of Harbin Medical University, Harbin

200127

Shanghai Renji Hospital, Shanghai

250013

The First Affiliated Hospital of Shandong First Medical University, Jinan

250021

Shandong Provincial Hospital, Jinan

257034

Shengli Oilfield Central Hospital, Dongying

310016

Sir Run Run Shaw Hospital, Hangzhou

318050

Taizhou Hospital of Zhejiang Province, Taizhou

430022

Wuhan Asia Heart Hospital, Wuhan

451464

Fuwai Central China Cardiovascular Hospital, Zhengzhou

510235

Sun Yat-sen Memorial Hospital, Guangzhou

Unknown

Jiangsu Provincial Hospital, Nanjing

All Listed Sponsors
collaborator

Heart Health Research Centre

UNKNOWN

collaborator

The George Institute for Global Health, China

OTHER

collaborator

The George Institute for Global Health, Australia

OTHER

collaborator

Fukuoka University

OTHER

lead

Beijing Anzhen Hospital

OTHER

NCT04497376 - Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation | Biotech Hunter | Biotech Hunter