Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas

Persistent Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06124690
• Other study ID #: Stuttgart, EP-004
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Catheter Ablation
• Persistent Atrial Fibrillation

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