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Completed

NCT Number: NCT07175727

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

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.

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Key information

Conditions

Atrial Fibrillation (Paroxysmal) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alfried Krupp Hospital

Essen, North Rhine-Westphalia, 45131, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pulmonary vein isolation

Device

Pulmonary vein isolation for paroxysmal atrial fibrillation

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.

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.

Primary outcomes

  1. Primary outcome: Freedom from arrhythmia

    Time frame: 12 months follow-up

    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.

Secondary outcomes

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

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Alfried Krupp Krankenhaus

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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