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Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas

Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas: a Prospective Randomized Trial

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06124690
Enrollment
150
Registered
2023-11-09
Start date
2023-09-01
Completion date
2025-09-01
Last updated
2024-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Ablation, Low Voltage Areas, Persistent Atrial Fibrillation

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.

Interventions

DEVICECatheter ablation

Pulmonary vein isolation and ablation of low voltage areas.

Sponsors

Robert Bosch Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Minors

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with atrial arrhythmia recurrence after 12 months follow-up12 monthsNumber of participants with atrial arrhythmia recurrence after 12 months follow-up

Secondary

MeasureTime frameDescription
Number of procedural complications12 monthsNumber of procedural complications.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026