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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation (Paroxysmal)
• Intervention / Treatment: Device: Pulmonary vein isolation; Radiation: cerebral magnetic resonance tomography; Diagnostic test: Biomarker assessment (C-reacitve Protein, troponine)

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Essen, North Rhine-Westphalia, Germany, 45131
      • Alfried Krupp Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Recurrent, symptomatic paroxysmal atrial fibrillation
• Age > 18 years
• Patient consen

Exclusion Criteria:

• Refusal of the patient
• Inability to provide informed consent
• Life expectancy < 2 years
• Pregnancy and breastfeeding (due to radiation exposure)
• History of left atrial ablation
• Known macro-reentry or focal atrial tachycardia
• Significant mitral valve stenosis
• History of heart valve replacement or reconstruction
• NYHA class III and IV
• Left ventricular ejection fraction < 35%
• Left atrial enlargement > 55 mm on echocardiography
• Intracardiac thrombus prior to the procedure
• Severe pulmonary disease with abnormal blood gases or requiring oxygen therapy
• Renal insufficiency (GFR < 30 mL/min) due to contrast medium use
• Stroke or TIA within the last 6 months
• Symptomatic carotid stenosis
• Active malignancy within the previous 24 months
• Untreated or uncontrolled thyroid disease
• Active bleeding or chronic bleeding tendency not amenable to curative treatment
• Body mass index > 35 kg/m²
• Contraindication to CT examination (e.g., contrast medium allergy or severe claustrophobia)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single-Shot Pulsed Field Ablation; Single-Shot Pulsed Field Ablation is performed using the FARAPULSE PFA System	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.
Active Comparator: Single-Tip Pulsed Field Ablation; Single-Tip Pulsed Field Ablation is performed using a conventional ablation catheter in combination with a pulsed field ablation generator.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome: Freedom from arrhythmia	The clinical efficacy, e.g. freedom from atrial arrhythmias / atrial fibrillation is assessed by 5-7 day Holter Monitoring at 3, 6 and 12 months after the procedure. Any documented arrhythmia episode lasting >30s was calculated as failure. A three months blanking period was considered.	12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcomes: Complications, Silent cerebral lesions (cMRI) and biomarker assessments	All peri-procedural complications were noted. In a subset of consecutive patients (n = 25 in each group), cerebral magnetic resonance tomography (cMRI) was performed on the day after the ablation procedure to assess silent cerebral lesions. In case of positive cMRI findings (e.g. silent lesion), repeat cMRI was scheduled in 6 weeks. Biomarker analyses were performed using blood samples, e.g. high-sensitive troponin release at 6, 24 and 48 hours after the ablation as a marker of myocardial injury and C-reactive proteine levels before and 24 hours after the ablation procedure to asses inflammatory response.	6 weeks

Collaborators and Investigators

• Sponsor: Alfried Krupp Krankenhaus
• Investigators: Principal Investigator: Kars Neven, MD, PhD, Alfried Krupp Hospital; Study Director: Stefan Hartl, Alfried Krupp Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2023
• Primary Completion (Actual): May 23, 2025
• Study Completion (Actual): May 23, 2025

Study Registration Dates

• First Submitted: August 28, 2025
• First Submitted That Met QC Criteria: September 8, 2025
• First Posted (Estimated): September 16, 2025

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Pulmonary Vein Isolation; Pulsed Field Ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: 224/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data are available upon reasonable request.
• IPD Sharing Time Frame: 1 year after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes