Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas
Study Details
Study Description
Brief Summary
An effective therapy of persistent atrial fibrillation beyond pulmonary vein isolation remains unsatisfactory. Targeting endocardial low-voltage areas represents an approach of substrate modification.
This prospective, randomized study investigated the efficacy of ablation of low-voltage areas versus PVI and additional linear ablations in patients with persistent atrial fibrillation in terms of single-procedure arrhythmia-free outcome and safety.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Pulmonary vein isolation has become the cornerstone of the interventional treatment of paroxysmal atrial fibrillation. For the treatment of persistent atrial fibrillation the data remains unclear. All different approaches remain unsatisfactory for the treatment of persistent atrial fibrillation, including single pulmonary vein isolation, targeting endocardial areas of low-voltage, identifying areas with complex fractionated atrial electrograms (CFAE), ablating linear lines such as an anterior line, a roof-line or mitral isthmus line. Recurrence rates are still higher as compared to paroxysmal atrial fibrillation ablation. Several studies showed a good correlation between the volume of low-voltage areas (LVA) and the burden of atrial fibrillation. Earlier studies that investigated ablation therapy using a substrate-guided ablation as compared to circumferential pulmonary vein isolation (CPVI) alone, mostly showed no significant difference in recurrence rates between both approaches. In contrast, some other studies showed better outcomes when targeting low-voltage areas. However, there was significant heterogeneity in patient selection, mapping and ablation strategies and therefore, comparisons are hard to make.
The patients are randomized into three different treatment arms (Group 1: PVI alone if no low voltage areas are detected, Group 2: PVI alone if low voltage areas are detected, Group 3: PVI plus ablation of low voltage areas.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Pulmonary vein isolation (no low voltage) Patients without the presence of low voltage areas receive pulmonary vein isolation only. |
Device: Catheter ablation
Pulmonary vein isolation and ablation of low voltage areas.
|
| Active Comparator: Pulmonary vein isolation only (evidence of low voltage areas) Patients with the evidence of low voltage areas are randomized to either pulmonary vein isolation only or PVI plus ablation of low voltage areas. |
Device: Catheter ablation
Pulmonary vein isolation and ablation of low voltage areas.
|
| Active Comparator: Pulmonary vein isolation plus ablation of low voltage areas Patients with the evidence of low voltage areas are randomized to either pulmonary vein isolation only or PVI plus ablation of low voltage areas. |
Device: Catheter ablation
Pulmonary vein isolation and ablation of low voltage areas.
|
Outcome Measures
Primary Outcome Measures
- Number of participants with atrial arrhythmia recurrence after 12 months follow-up [12 months]
Number of participants with atrial arrhythmia recurrence after 12 months follow-up
Secondary Outcome Measures
- Number of procedural complications [12 months]
Number of procedural complications.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Persistent atrial fibrillation according to the current guidelines
-
Age > 18 years
-
Patient information
Exclusion Criteria:
- Minors
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Robert Bosch Health Coampus | Stuttgart | Baden-Wuerttemberg | Germany | 70197 |
Sponsors and Collaborators
- Robert Bosch Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Stuttgart, EP-004