Lesion Formation With Pulsed Field Versus Cryobaloon Ablation as Assessed by Cardiac Magnetic Resoncance
Recruiting · NCT06220006 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Clinic of Barcelona
View the official record on ClinicalTrials.gov →Interventions studied
Pulmonary vein isolation
What this trial is about
This randomised study will compare pulsed field ablation and cryoballoon ablation with respect to ablation lesion quality as assessed by late gadolinium enhancement (LGE) cardiac magnetic resonance (CMR) at 3 months post-ablation. Patients scheduled for first-time AF ablation will be randomised in a 2:1 fashion to receive PVI-only, either by pulsed field ablation (Farapulse Pulsed Field Ablation System, Boston Scientific) or cryoballoon ablation (Medtronic Cryoballoon Ablation System).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients scheduled for first-time atrial fibrillation catheter ablation
Exclusion criteria
- age \<18 years
- long-standing persistent atrial fibrillation
- prior left atrial ablation
- pregnancy or lactation
- reduced left ventricular ejection fraction
- GFR \<30%
- BMI \>35%
- left atrial diameter \>55 mm
- cardiac implantable electronic device
Where it is running
1 location listed.
- Hospital Clinic, University of Barcelona - Barcelona, Catalonia, Spain