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NCT07175727
TWOSOME Trial: Single-Shot Versus Single-Tip Pulsed Field Ablation for Pulmonary Vein Isolation
NA trial testing Pulmonary vein isolation in Atrial Fibrillation (Paroxysmal) in 100 participants. Completed in 23 May 2025.
23 May 2025
Quick facts
| Lead sponsor | Alfried Krupp Krankenhaus |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 24 January 2023 |
| Primary completion | 23 May 2025 |
| Estimated completion | 23 May 2025 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Pulmonary vein isolation
- cerebral magnetic resonance tomography
- Biomarker assessment (C-reacitve Protein, troponine)
Conditions studied
- Atrial Fibrillation (Paroxysmal) — all drugs for Atrial Fibrillation (Paroxysmal) →
Sponsor
Alfried Krupp Krankenhaus
Who can join
18 and older, any sex, with Atrial Fibrillation (Paroxysmal). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07175727
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pulmonary vein isolation
Trials testing the same drug.
- NCT07450755 — Concomitant PFA Bsaed PVI Plus LAAC · NA · not yet recruiting
- NCT07118046 — Comparison of Fluoroscopy-only vs. Electroanatomic Mapping Strategies for Pulmonary Vein Isolation With Balloon-based Pu · NA · recruiting
- NCT06671197 — Study on the Ablation of Persistent Atrial Fibrillation Using Pulsed Electric Fields Under Different Surgical Procedures · not yet recruiting
- NCT06861673 — COCONUT Study Concomitant PVI and LAAC · recruiting
- NCT06096246 — Investigation of Cardioversion Versus Therapeutic Ablation for Persistent AF (ORBICA-AF) · NA · recruiting
Other recruiting trials for Atrial Fibrillation (Paroxysmal)
Currently open trials in the same condition.
- NCT07321964 — The Effect of a Digital MediYoga Program on Quality of Life, Blood Pressure and Heart Rate Among Patients With Atrial Fi · NA · recruiting
- NCT07171463 — Pulsed Field Ablation With Concomitant Radiofrequency Cardioneuroablation in Patients With Paroxysmal Atrial Fibrillatio · NA · recruiting
- NCT06828939 — Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF · NA · recruiting
- NCT06698159 — Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI) · NA · recruiting
- NCT07358429 — CPAP Therapy and Atrial Fibrillation Recurrence in OSA · active not recruiting
Other Alfried Krupp Krankenhaus trials
Trials by the same sponsor.
- NCT04075500 — Optimal Detection of Atrial Fibrillation in TIA · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07175727 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alfried Krupp Krankenhaus
- Last refreshed: 16 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07175727.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing