Lesion Formation With Pulsed Field Versus Cryobaloon Ablation as Assessed by Cardiac Magnetic Resoncance (PULSED-ICE-CMR)

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).

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Pulmonary vein isolation

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.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Recruiting
      • Hospital Clinic, University of Barcelona
      • Contact: Ivo Roca-Luque, M.D.; Phone Number: +34932275551; Email: iroca@clinic.cat
      • Sub-Investigator: Lluis Mont, M.D.
      • Sub-Investigator: Till F Althoff, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulsed Field Ablation; Pulmonary vein isolation using the Farapulse Pulsed Field Ablation System (Boston Scientific)	Procedure: Pulmonary vein isolation; Catheter ablation
Active Comparator: Cryoballoon Ablation; Pulmonary vein isolation using the Medtronic Cryoballoon Ablation System	Procedure: Pulmonary vein isolation; Catheter ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LGE-CMR-determined ablation lesion quality	Complete late gadolinium enhancement encircling both pulmonarz vein pairs, with discontinuations adding up to less than 10% of the total length of the circumference	3 months post-ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AF-free survival		3, 6 and 12 months post-ablation
Arrhythmia-free survival	Freedom from atrial tachycardia, atrial flutter and AF	3, 6 and 12 months post-ablation
Time to first AF recurrence		12, 24 and 36 months
Progression from paroxysmal to persistent AF		12, 24 and 36 months
Time to first arrhythmia		12, 24 and 36 months
Spatial LGE distribution according to local wall thickness (as assessed by preablation CT)		3 months post-ablation
Complete pulmonary vein isolation confirmed by persistent entrance- and exit-block	(per-pulmonary vein pair analysis and per-patient analysis	intra-procedural
Safety events	Vascular access complications, pericardial effusion / tamponade, phrenic nerve paly (temporal or permanent), atrio-esophageal fistula, esophageal ulcer, pulmonary vein stenosis, systemic embolism, stroke, TIA, death, cardiovascular death	periprocedural and 12 months

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): November 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Catheter ablation; Cardiac magnetic resonance; Cryoballoon ablation; Pulmonary vein isolation; Pulsed field ablation; Late gadolinium enhancement; Ablation lesion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: PULSED-ICE-CMR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No