Atrial Fibrillation (Paroxysmal)NCT07175727
TWOSOME Trial: Single-Shot Versus Single-Tip Pulsed Field Ablation for Pulmonary Vein Isolation
A study testing Pulmonary vein isolation, cerebral magnetic resonance tomography and Biomarker assessment (C-reacitve Protein, troponine) in people with Atrial Fibrillation (Paroxysmal), run by Alfried Krupp Krankenhaus at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (Paroxysmal)
- What is being tested?
- Pulmonary vein isolation, cerebral magnetic resonance tomography and Biomarker assessment (C-reacitve Protein, troponine)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jan 2023to 23 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent, symptomatic paroxysmal atrial fibrillation
- Age > 18 years
- Patient consen
Who cannot join
- 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
Show all 21Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Being tested
- Pulmonary vein isolation, cerebral magnetic resonance tomography, Biomarker assessment (C-reacitve Protein, troponine)
- Keywords
- Pulsed Field Ablation, Pulmonary Vein Isolation, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationDevice
Pulmonary vein isolation for paroxysmal atrial fibrillation
cerebral magnetic resonance tomographyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-Shot Pulsed Field Ablation | Active comparator | Single-Shot Pulsed Field Ablation is performed using the FARAPULSE PFA System Receives: 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. Receives: Device: Pulmonary vein isolation; Radiation: cerebral magnetic resonance tomography; Diagnostic Test: Biomarker assessment (C-reacitve Protein, troponine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months follow-up
Secondary outcomes (1)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start24 Jan 2023
- Primary completion23 May 2025
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (Paroxysmal)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfried Krupp Krankenhaus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kars Neven, Alfried Krupp Krankenhaus
- Investigators
- Kars Neven, MD, PhD, Principal investigator, Alfried Krupp HospitalStefan Hartl, Study director, Alfried Krupp Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175727
- Sponsor's protocol ID
- 224/2022
- Status last verified
- Jan 2023
- First submitted
- 28 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data are available upon reasonable request.
Publications
Hartl S, Reinsch N, Futing A, El-Battrawy I, Tiemessen M, Waldt S, Pongratz J, Neven K. Cerebral Safety of Two Pulsed Field Ablation Workflows for Pulmonary Vein Isolation: Results From the Randomized TWOSOME MRI Study. J Cardiovasc Electrophysiol. 2026 Oct 25. doi: 10.1111/jce.70544. Online ahead of print.
PubMed 42927651
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of New, Non-thermal Ablation Techniques for the Treatment of Atrial Fibrillation - A Comparison of Two Ablation Systems
- ClinicalTrials.gov ID
- NCT07175727
- Acronym / sponsor ID
- 224/2022
- Conditions
- Atrial Fibrillation (Paroxysmal)
- Keywords
- Pulsed Field Ablation, Pulmonary Vein Isolation, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alfried Krupp KrankenhausUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Shot Pulsed Field Ablation | Active comparator | Device: Pulmonary vein isolation, Radiation: cerebral magnetic resonance tomography, Diagnostic Test: Biomarker assessment (C-reacitve Protein, troponine)Single-Shot Pulsed Field Ablation is performed using the FARAPULSE PFA System |
| Single-Tip Pulsed Field Ablation | Active comparator | Device: Pulmonary vein isolation, Radiation: cerebral magnetic resonance tomography, Diagnostic Test: Biomarker assessment (C-reacitve Protein, troponine)Single-Tip Pulsed Field Ablation is performed using a conventional ablation catheter in combination with a pulsed field ablation generator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recurrent, symptomatic paroxysmal atrial fibrillation
- Age > 18 years
- Patient consen
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary vein isolationPulmonary vein isolation for paroxysmal atrial fibrillation | Device | Single-Shot Pulsed Field Ablation, Single-Tip Pulsed Field Ablation |
| cerebral magnetic resonance tomographyA 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. | Radiation | Single-Shot Pulsed Field Ablation, Single-Tip Pulsed Field Ablation |
| 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. | Diagnostic test | Single-Shot Pulsed Field Ablation, Single-Tip Pulsed Field Ablation |
Primary outcome
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.
1 secondary outcome
Secondary outcomes: Complications, Silent cerebral lesions (cMRI) and biomarker assessments
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Derived from this study: PubMed 42927651Hartl S, Reinsch N, Futing A, El-Battrawy I, Tiemessen M, Waldt S, Pongratz J, Neven K. Cerebral Safety of Two Pulsed Field Ablation Workflows for Pulmonary Vein Isolation: Results From the Randomized TWOSOME MRI Study. J Cardiovasc Electrophysiol. 2026 Oct 25. doi: 10.1111/jce.70544. Online ahead of print.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kars Neven, MD, PhD principal investigator
Alfried Krupp Hospital
Stefan Hartl study director
Alfried Krupp Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation, cerebral magnetic resonance tomography and Biomarker assessment (C-reacitve Protein, troponine) in people with Atrial Fibrillation (Paroxysmal), run by Alfried Krupp Krankenhaus at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: Freedom from arrhythmia (time frame: 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07175727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.