Lesion Formation With Pulsed Field Versus Cryobaloon Ablation as Assessed by Cardiac Magnetic Resoncance

NCT ID: NCT06220006

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-11-01

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).

Detailed Description

Pulmonary vein isolation (PVI) using catheter ablation has become a cornerstone in the treatment of AF and is considered the most effective therapy today. Catheter ablation has been mostly performed employing thermal energies, with radiofrequency and cryo-balloon ablation being the best validated most widely applied modalities. Despite substantial technological and procedural advances that have improved efficacy, efficiency and safety of AF ablation in recent years, long-term durability of ablation lesions is still not satisfactory, and rare but potentially life-threatening procedure-related complications like cardiac tamponade or atrio-esophageal fistula remain a concern. In addition, phrenic nerve palsy complicates a relevant proportion of procedures, particularly in cryo-ablation.

The novel non-thermal ablation method of pulsed field ablation holds great promise in that respect. Pulsed field ablation achieves permanent cell death through electroporation, which appears to provide a unique selectivity for cardiomyocytes and to spare surrounding tissues composed of other cell types, thus minimising the risk of collateral damage.This method has already been introduced into routine clinical practice and is established in many centers worldwide. A large number of studies have confirmed safety and efficacy of pulsed field ablation for pulmonary vein isolation in the context of AF and found significant reductions in ablation times. However, the putative benefits regarding efficacy, efficiency and safety remain to be proven in randomised controlled trials.

Against this background, the investigators aim to perform a randomised clinical trial comparing pulsed field ablation with thermal cryo-balloon ablation with respect to efficacy, effectiveness and safety. 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). The primary outcome of this trial will be ablation lesion quality as assessed by late gadolinium enhancement (LGE) cardiac magnetic resonance (CMR) at 3 months post-ablation.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pulsed Field Ablation

Pulmonary vein isolation using the Farapulse Pulsed Field Ablation System (Boston Scientific)

Group Type: EXPERIMENTAL

Pulmonary vein isolation

Intervention Type: PROCEDURE

Catheter ablation

Cryoballoon Ablation

Pulmonary vein isolation using the Medtronic Cryoballoon Ablation System

Group Type: ACTIVE_COMPARATOR

Pulmonary vein isolation

Intervention Type: PROCEDURE

Catheter ablation

Interventions

Pulmonary vein isolation

Catheter ablation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Ivo Roca

Head of Arrhythmia Section. Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Clinic, University of Barcelona

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Ivo Roca-Luque, M.D.

Role: primary

iroca@clinic.cat

+34932275551

Other Identifiers

PULSED-ICE-CMR

Identifier Type: -

Identifier Source: org_study_id