NCT07175727Completed
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
Source: ClinicalTrials.gov · Last updated 16 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 28 Aug 2025
- Start date
- 24 Jan 2023
- Primary completion date
- 23 May 2025
- Lead sponsor
- Alfried Krupp Krankenhaus
- Diseases
- Atrial fibrillation
- NCT number
- NCT07175727
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 24 Jan 2023 to the primary completion date, 23 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnancy and breastfeeding (due to radiation exposure)
- Intracardiac thrombus prior to the procedure
- Active malignancy within the previous 24 months
Other illness
- History of left atrial ablation
- History of heart valve replacement or reconstruction
- Severe pulmonary disease with abnormal blood gases or requiring oxygen therapy
- Stroke or TIA within the last 6 months
- Untreated or uncontrolled thyroid disease
- Active bleeding or chronic bleeding tendency not amenable to curative treatment
- Contraindication to CT examination (e.g., contrast medium allergy or severe claustrophobia)
Lab values
- Left ventricular ejection fraction \< 35%
- Renal insufficiency (GFR \< 30 mL/min) due to contrast medium use
Age
- Life expectancy \< 2 years
Other
- Refusal of the patient
- Inability to provide informed consent
- Known macro-reentry or focal atrial tachycardia
- Significant mitral valve stenosis
- NYHA class III and IV
- Left atrial enlargement \> 55 mm on echocardiography
- Symptomatic carotid stenosis
- Body mass index \> 35 kg/m²
Who the study is looking for
- Recurrent, symptomatic paroxysmal atrial fibrillation
- Age \> 18 years
- Patient consen
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alfried Krupp Hospital Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
Related publications
- Cerebral Safety of Two Pulsed Field Ablation Workflows for Pulmonary Vein Isolation: Results From the Randomized TWOSOME MRI Study.J Cardiovasc Electrophysiol · 2026 · PMID 42927651
This page is information, not medical advice. Discuss any trial with your doctor.