NCT06220006 Lesion Formation With Pulsed Field Versus Cryobaloon Ablation as Assessed by Cardiac Magnetic Resoncance
| NCT ID | NCT06220006 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Clinic of Barcelona |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 104 participants in total. It began in 2023-11-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT06220006 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06220006 currently recruiting?
Yes, NCT06220006 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hospital Clinic of Barcelona to inquire about joining.
Where is the NCT06220006 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06220006 clinical trial?
NCT06220006 is sponsored by Hospital Clinic of Barcelona. The trial plans to enroll 104 participants.
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