Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas

NCT06124690 | Active Not Recruiting DMC

• 1 other identifier: Stuttgart, EP-004
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Atrial Fibrillation; Catheter Ablation; Low Voltage Areas

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of procedural complications

  12 months

Study Arms (3)

Pulmonary vein isolation (no low voltage)

ACTIVE COMPARATOR

Patients without the presence of low voltage areas receive pulmonary vein isolation only.

Device: Catheter ablation

Pulmonary vein isolation only (evidence of low voltage areas)

ACTIVE COMPARATOR

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 plus ablation of low voltage areas

ACTIVE COMPARATOR

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

Interventions

Catheter ablation DEVICE

Pulmonary vein isolation and ablation of low voltage areas.

Pulmonary vein isolation (no low voltage); Pulmonary vein isolation only (evidence of low voltage areas); Pulmonary vein isolation plus ablation of low voltage areas

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Minors

Sponsors & Collaborators

• Robert Bosch Medical Center: lead

Study Sites (1)

Robert Bosch Health Coampus

Stuttgart, Baden-Wurttemberg, 70197, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invetsigator, Head of Electrophysiology

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: November 9, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)