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

Atrial Fibrillation Clinical Trial

— PULSED-ICE-CMR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220006
• Other study ID #: PULSED-ICE-CMR
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 1, 2026

Study information

• Verified date: January 2024
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Pulmonary vein isolation
Catheter ablation

Locations

Country	Name	City	State
Spain	Hospital Clinic, University of Barcelona	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AF-free survival		3, 6 and 12 months post-ablation
Secondary	Arrhythmia-free survival	Freedom from atrial tachycardia, atrial flutter and AF	3, 6 and 12 months post-ablation
Secondary	Time to first AF recurrence		12, 24 and 36 months
Secondary	Progression from paroxysmal to persistent AF		12, 24 and 36 months
Secondary	Time to first arrhythmia		12, 24 and 36 months
Secondary	Spatial LGE distribution according to local wall thickness (as assessed by preablation CT)		3 months post-ablation
Secondary	Complete pulmonary vein isolation confirmed by persistent entrance- and exit-block	(per-pulmonary vein pair analysis and per-patient analysis	intra-procedural
Secondary	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