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

NCT07175727 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-09-16

No results posted yet for this study

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)

Interventions

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.

Sponsors & Collaborators

  • Alfried Krupp Krankenhaus

    lead OTHER

Principal Investigators

  • Kars Neven, MD, PhD · Alfried Krupp Hospital

  • Stefan Hartl · Alfried Krupp Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-24
Primary Completion
2025-05-23
Completion
2025-05-23
FDA Device
Yes

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07175727 on ClinicalTrials.gov