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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06124690
Other study ID # Stuttgart, EP-004
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date September 1, 2025

Study information

Verified date November 2023
Source Robert Bosch Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date September 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Persistent atrial fibrillation according to the current guidelines - Age > 18 years - Patient information Exclusion Criteria: - Minors

Study Design


Intervention

Device:
Catheter ablation
Pulmonary vein isolation and ablation of low voltage areas.

Locations

Country Name City State
Germany Robert Bosch Health Coampus Stuttgart Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor Collaborator
Robert Bosch Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with atrial arrhythmia recurrence after 12 months follow-up Number of participants with atrial arrhythmia recurrence after 12 months follow-up 12 months
Secondary Number of procedural complications Number of procedural complications. 12 months
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