Status:
COMPLETED
TWOSOME Trial: Single-Shot Versus Single-Tip Pulsed Field Ablation for Pulmonary Vein Isolation
Lead Sponsor:
Alfried Krupp Krankenhaus
Conditions:
Atrial Fibrillation (Paroxysmal)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 patien...
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 (Galvan...
Eligibility Criteria
Inclusion
- Recurrent, symptomatic paroxysmal atrial fibrillation
- Age \> 18 years
- Patient consen
Exclusion
- 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)
Key Trial Info
Start Date :
January 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07175727
Start Date
January 24 2023
End Date
May 23 2025
Last Update
September 16 2025
Active Locations (1)
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1
Alfried Krupp Hospital
Essen, North Rhine-Westphalia, Germany, 45131