NCT07175727

TWOSOME Trial: Single-Shot Versus Single-Tip Pulsed Field Ablation for Pulmonary Vein Isolation

Safety and Efficacy of New, Non-thermal Ablation Techniques for the Treatment of Atrial Fibrillation - A Comparison of Two Ablation Systems

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Alfried Krupp Krankenhaus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Two non-thermal ablation techniques approved for routine clinical practice (CE-marked) for the interventional treatment of atrial fibrillation are compared in a 1:1 randomization to investigate patient data, procedural data, effectiveness, and safety.

Detailed description

Patients with paroxysmal atrial fibrillation were randomized 1:1 to undergo pulmonary vein isolation using pulsed field ablation (PFA) with either single-shot PFA (FARAPULSE) or single-tip PFA (Galvanize Therapeutics). Baseline characteristics, procedural data, effectiveness, and safety outcomes were analyzed. In each group, a subset of consecutive patients underwent cerebral magnetic resonance imaging to assess silent cerebral lesions and was scheduled for biomarker assessment (blood sampling) to evaluate inflammation and troponin release after PFA.

Conditions

• Atrial Fibrillation (Paroxysmal)

Interventions

Type	Name	Description
DEVICE	Pulmonary vein isolation	Pulmonary vein isolation for paroxysmal atrial fibrillation
RADIATION	cerebral magnetic resonance tomography	A subset of consecutive patients of each group (n=25 of each group) receives cMRI on the day after the procedure to asses silent cerebral lesions. A control cMRI is scheduled in case of positive findings.
DIAGNOSTIC_TEST	Biomarker assessment (C-reacitve Protein, troponine)	A subset of patients of each group (n=25 of each group) received blood tests to asses inflammation and troponine release.

Timeline

• Start date: 2023-01-24
• Primary completion: 2025-05-23
• Completion: 2025-05-23
• First posted: 2025-09-16
• Last updated: 2025-09-16

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study