Clinical trial NCT02477592: a Novel Individualized Substrate Modification Approach for the Treatment of Long-standing Persistent Atrial Fibrillation
Official title: A Prospective Randomized Study of a Novel Individualized Substrate Modification Approach Versus Stepwise Ablation for the Treatment of Long-standing Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: long standing persistent atrial fibrillation
novel approach
ablation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2015-06-23
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: atrial fibrillation free rate on or off antiarrhythmic drugs (AADs) after initial ablation
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with adverse event
timeFrame: 1 year
measure: Prevalence of recurrent atrial flutter
timeFrame: 1 year
measure: Proportion of pulmonary vein isolation
timeFrame: 1 year
measure: Proportion of acute pulmonary vein re-connection
timeFrame: 1 year
measure: Fluoroscopy exposure time
timeFrame: 1 year
measure: Total ablation time
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiaotong University school of medicine,Renji Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Xinhua Wang, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
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