Clinical trial NCT06124690: Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas
Official title: Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Persistent Atrial Fibrillation
Catheter Ablation
Low Voltage Areas
Lead sponsor: Robert Bosch Medical Center
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with persistent atrial fibrillation are included in the study. They are randomized into three diffrenet treatment arms depending on the presence of left atrial fibrosis.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Persistent atrial fibrillation according to the current guidelines
* Age \> 18 years
* Patient information

Exclusion Criteria:

* Minors

Primary outcomes:
measure: Number of participants with atrial arrhythmia recurrence after 12 months follow-up
timeFrame: 12 months
Secondary outcomes:
measure: Number of procedural complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert Bosch Health Coampus
state: Baden-Wuerttemberg
Study officials:
References: