Atrial Fibrillation
Conditions
Keywords
long standing persistent atrial fibrillation, novel approach, ablation
Brief summary
The purpose of this study is to compare effectiveness of two substrate modification approaches in long-standing persistent atrial fibrillation patients, and hypothesized that a substrate-based, individualized substrate modification (ISM)approach should be superior to traditional stepwise ablation(SA). To the best of investigator's knowledge, this was the first study to evaluate the real substrate by means of electro-anatomic mapping and to perform true substrate modification in long standing persistent atrial fibrillation ablation(LPAF).
Detailed description
Catheter ablation (CA) is highly effective for paroxysmal atrial fibrillation(AF), it is modestly effective for long standing persistent atrial fibrillation ablation(LPAF) even with complex or combined approaches, which is mainly attributed to the substrate underlying AF remodeling. Severity of atrial fibrosis is closely associated with clinical outcomes after CA for AF . The more atrial scars and fibrosis present, the lower the success rate for AF ablation. Patients with LPAF have many more areas with scars and fibrosis than those with paroxysmal AF or non-AF controls. The MRI delayed enhancement technique provides a non-interventional tool for evaluation of atrial fibrosis, however, it must be performed in sinus rhythm.Three-dimensional electro anatomic mapping has proven as accurate as MRI and can be performed easily during AF ablation, thus providing a good tool for evaluation of atrial substrate during LPAF ablation. Although electro-anatomic mapping provided a desirable surrogate for delayed enhancement MRI to define AF substrate, there was an important technical issue to be considered. There were no good techniques to predict a desirable tip-tissue contact before the contact force catheter was applied. A poor tip-tissue contact could render the results of voltage mapping less reliable. On the other hand, excessively high contact force could increase the risk of steam pop and cardiac perforation during ablation. Hence it was important to use the contact force catheter to perform substrate mapping and ablation.
Interventions
PROCEDUREindividualized substrate modification
CPVI ablation and left atrial roof linear ablation first,then substrate mapping in sinus rhythm followed by individualized substrate modification.
PROCEDUREstepwise ablation
CPVI ablation,left atrial roof linear ablation,mitral isthmus linear ablation,complex fractionated atrial electrograms ablation step by step.
Sponsors
Biosense Webster, Inc.
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 and ≤ 72years * History of LPAF for ≥1 and ≤ 5 years * Written informed consent provided * Acceptance of catheter ablation treatment * Acceptance of post-ablation follow-up
Exclusion criteria
* Prior history of catheter ablation or surgical ablation * Abnormal coagulation; contraindication for anti-coagulation * left atrium diameter ≥ 55mm * left atrium thrombus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| atrial fibrillation free rate on or off antiarrhythmic drugs (AADs) after initial ablation | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of recurrent atrial flutter | 1 year | — |
| Proportion of pulmonary vein isolation | 1 year | — |
| Number of participants with adverse event | 1 year | pericardial tamponade and thromboembolism event |
| Fluoroscopy exposure time | 1 year | — |
| Total ablation time | 1 year | — |
| Proportion of acute pulmonary vein re-connection | 1 year | — |
Countries
China
Contacts
Primary ContactXinhua Wang, MD,PHD
Outcome results
None listed