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

NCT07175727 | Completed FDA Device

• 1 other identifier: 224/2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation (Paroxysmal)

Keywords

Pulsed Field Ablation; Pulmonary Vein Isolation; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary outcomes: Complications, Silent cerebral lesions (cMRI) and biomarker assessments

  6 weeks

Study Arms (2)

Single-Shot Pulsed Field Ablation

ACTIVE COMPARATOR

Single-Shot Pulsed Field Ablation is performed using the FARAPULSE PFA System

Device: Pulmonary vein isolation; Radiation: cerebral magnetic resonance tomography; Diagnostic Test: Biomarker assessment (C-reacitve Protein, troponine)

Single-Tip Pulsed Field Ablation

ACTIVE COMPARATOR

Single-Tip Pulsed Field Ablation is performed using a conventional ablation catheter in combination with a pulsed field ablation generator.

Device: Pulmonary vein isolation; Radiation: cerebral magnetic resonance tomography; Diagnostic Test: Biomarker assessment (C-reacitve Protein, troponine)

Interventions

Pulmonary vein isolation DEVICE

Pulmonary vein isolation for paroxysmal atrial fibrillation

Single-Shot Pulsed Field Ablation; Single-Tip Pulsed Field Ablation

cerebral magnetic resonance tomography RADIATION

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.

Single-Shot Pulsed Field Ablation; Single-Tip Pulsed Field Ablation

Biomarker assessment (C-reacitve Protein, troponine) DIAGNOSTIC_TEST

A subset of patients of each group (n=25 of each group) received blood tests to asses inflammation and troponine release.

Single-Shot Pulsed Field Ablation; Single-Tip Pulsed Field Ablation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alfried Krupp Krankenhaus: lead

Study Sites (1)

Alfried Krupp Hospital

Essen, North Rhine-Westphalia, 45131, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Kars Neven, MD, PhD

  Alfried Krupp Hospital

  PRINCIPAL INVESTIGATOR

• Stefan Hartl

  Alfried Krupp Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD.

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 16, 2025
• Study Start: January 24, 2023
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: September 16, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year after publication

Locations

DE (1)