Recurrent Persistent Atrial Fibrillation
Conditions
Brief summary
This is an open label, randomized parallel control clinical trial, to compare extra-PV extensive ablation with in-situ ablation as two strategies for the treatment of PerAF to identify the mechanisms of PerAF recurrence.
Detailed description
This is an open label, randomized parallel control clinical trial. Patients with recurrent persistent atrial fibrillation are 1:1 randomized into EXT group(Extra-PV extensive ablation) and IN-SITU group(Repeat same PVI and linear ablation as the first procedure). Postoperative recurrence rate and other indicators are analyzed to compare extra-PV extensive ablation with in-situ ablation as two strategies for the treatment of PerAF to identify the mechanisms of PerAF recurrence.
Interventions
PROCEDUREExtra-PV extensive ablation
Extra-PV extensive ablation
PROCEDURERepeat same PVI and linear ablation as the first procedure
Repeat same PVI and linear ablation as the first procedure
Sponsors
Jinshan Hospital Affiliated to Fudan University
Tongji University
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older; 2) Diagnosed as recurrent PerAF according to the latest clinical guidelines; 3) Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment; 4) the first ablation procedure was PVI and linear ablation; 5) consented to receive radiofrequency catheter ablation.
Exclusion criteria
* 1\) Recurrent atrial flutter/atrial tachycardia; 2) The first ablation procedure included extra-PV substrate ablation; 3) The first low voltage area\>30%; 4) Serious complications during the first procedure; 5) The first ablation was paroxysmal atrial fibrillation. 6) Uncontrolled congestive heart failure; 7) History of severe valve disease and/or prosthetic valve replacement; 8) Left atrial thrombus confirmed by preoperative esophageal ultrasound; 9) Severe congenital heart disease; 10) Severe lung disease; 11) Left atrial diameter ≥60mm; 12) Contraindications for cardiac catheterization; 13) Myocardial infarction or stroke within 6 months; 14) Contrast agent allergy; 15) The use of anticoagulant drugs is contraindicated; 16) Have performed any cardiac surgery within 2 months;17) life expectancy is less than one year, including factors such as physical inability to tolerate ablation or unstable disease conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from any documented AF/AT episode | 12 months | Freedom from any documented AF/AT episode lasting more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months' follow-up after a single ablation procedure without antiarrhythmic medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from any documented AF episode | 12 months | Freedom from any documented AF episode lasting more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months' follow-up after a single ablation procedure without antiarrhythmic medication |
| Any documented AT episode | 12 months | Any documented AT episode lasting more than 30 seconds excluding the initial 3 months blanking period, at a minimum of 12 months' follow-up after a single ablation procedure without antiarrhythmic medication |
| Periprocedural complications | 12 months | Periprocedural complications,including stroke, PV stenosis, cardiac perforation, oesophageal injury and death. |
Countries
China
Outcome results
None listed