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

About this trial

Last updated 9 months ago

Study ID

224/2022

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Ended a year ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* Recurrent, symptomatic paroxysmal atrial fibrillation

* Age > 18 years

* Patient consen

Exclusion Criteria

* 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)