An interventional study of AF-termination Group and Prespecified-ablation Group in Atrial Fibrillation, Cathter Ablation and Endpoint, sponsored by Shanghai Chest Hospital. Completed at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Treatment
This is a prospective, randomized, multi-center trial that aims to investigate whether termination of atrial fibrillation can be used as an ablation endpoint for persistent atrial fibrillation (PersAF). Eligible patients who provided consent were randomly assigned to one of two groups: the AF-termination group (whose ablation endpoint was the pursuit of AF-termination) or the prespecified-ablation group (whose ablation endpoint was prespecified ablation followed by electrical cardioversion).
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 480 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.
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Exclusion Criteria:
Procedure: AF-termination Group
Procedure: Prespecified-ablation Group
Each center completes the ablation according to the above ablation procedure. The choice of ablation strategy is not restricted, but efforts should be made to achieve termination of AF during the ablation procedure. If cannot terminate AF for safety or other reasons involving difficulties to remap AFEGM or creating a complete conduction block despite the operator's best efforts, then direct current conversion (DCCV) was performed.
Each center completes the prespecified ablation according to the above ablation procedure. Although there is no restriction on the choice of ablation strategy, Ablation must be performed following the PVI plus strategy, which can be combined with one or more additional ablation procedures, but each ablation must achieve its own endpoints, such as bidirectional block of linear damage, posterior wall isolation, etc. After completing the preset ablation steps, DCCV will be performed. If AF is terminated after or during ablation, it is also considered the endpoint of ablation in this group, but the preset ablation steps must be completed.
freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period
All patients included in the study had no incidence of Atrial fibrillation (AF), atrial tachycardia (AT) or Atrial flutter (AFL) at 12 months after ablation, excluding the initial 3-month blank period
Time frame: Time Frame: 12 months
freedom from AF/AT after a single procedure without AADs (excludes the blanking period)
All patients included in the study had no incidence of AF/AT after a single procedure without AADs at 12 months after ablation excluding the initial 3-month blank period
Time frame: Time Frame: 12 months
freedom from AF/AT after a single procedure with or without anti-arrhythmic medications (excludes the blanking period)
All patients included in the study had no incidence of freedom from AF/AT after a single procedure with or without anti-arrhythmic medications at 12 months after ablation excluding the initial 3-month blank period
Time frame: Time Frame: 12 months
any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment
All patients included in the study had no incidence of any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment at 12 months after ablation, excluding the initial 3-month blank period
Time frame: Time Frame: 12 months
freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure
All patients included in the study had no incidence of any AT episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment at 12 months after ablation, excluding the initial 3-month blank period
Time frame: Time Frame: 12 months
procedural details
All patients' procedural details: including procedure time, mapping time, fluoroscopy time, ablation time.
Time frame: Time Frame: 12 months
incidence of periprocedural adverse events
All patients' periprocedural adverse events including：ascular- significant groin，haematoma, pseudoaneurysm, AV fistula，Cardiac perforation，Pericardial effusion/ tamponade，Pericarditis，Pneumothorax/ haemothorax，Phrenic nerve injury，Periprocedural cerebrovascular accident - including air embolism，Esophageal injury - perforation / atrio-esophageal fistula，Pulmonary vein stenosis，Major bleeding event -including retroperitoneal bleeding，Heart block，Death
Time frame: Time Frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Shanghai Chest Hospital