NCT06220006

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
6mo left

Started Nov 2023

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Nov 2023Nov 2026

First Submitted

Initial submission to the registry

September 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

September 18, 2023

Last Update Submit

March 14, 2025

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationCatheter ablationAblation lesionPulmonary vein isolationPulsed field ablationCryoballoon ablationCardiac magnetic resonanceLate gadolinium enhancement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • AF-free survival

    3, 6 and 12 months post-ablation

  • Arrhythmia-free survival

    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

  • +3 more secondary outcomes

Study Arms (2)

Pulsed Field Ablation

EXPERIMENTAL

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

Procedure: Pulmonary vein isolation

Cryoballoon Ablation

ACTIVE COMPARATOR

Pulmonary vein isolation using the Medtronic Cryoballoon Ablation System

Procedure: Pulmonary vein isolation

Interventions

Pulmonary vein isolationPROCEDURE

Catheter ablation

Cryoballoon AblationPulsed Field Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for first-time atrial fibrillation catheter ablation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic, University of Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Arrhythmia Section. Professor of Cardiology

Study Record Dates

First Submitted

September 18, 2023

First Posted

January 23, 2024

Study Start

November 1, 2023

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)