Atrial FibrillationPULSED-ICE-CMRNCT06220006
Lesion Formation With Pulsed Field Versus Cryobaloon Ablation as Assessed by Cardiac Magnetic Resoncance
A study testing Pulmonary vein isolation in people with Atrial Fibrillation, run by Hospital Clinic of Barcelona at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2023to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for first-time atrial fibrillation catheter ablation
Who cannot join
- age <18 years
- long-standing persistent atrial fibrillation
- prior left atrial ablation
- pregnancy or lactation
- reduced left ventricular ejection fraction
- GFR <30%
Show all 9Show fewer
- BMI >35%
- left atrial diameter >55 mm
- cardiac implantable electronic device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic, University of Barcelona
Barcelona, Catalonia, 08036
Ivo Roca-Luque, M.D., +34932275551, iroca@clinic.cat
Lluis Mont, M.D.
About this study
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).
Read the 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
- Being tested
- Pulmonary vein isolation
- Keywords
- Atrial fibrillation, Catheter ablation, Ablation lesion, Pulmonary vein isolation, Pulsed field ablation, Cryoballoon ablation, Cardiac magnetic resonance, Late gadolinium enhancement
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationProcedure or surgery
Catheter ablation
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Field Ablation | Experimental | Pulmonary vein isolation using the Farapulse Pulsed Field Ablation System (Boston Scientific) Receives: Procedure: Pulmonary vein isolation |
| Cryoballoon Ablation | Active comparator | Pulmonary vein isolation using the Medtronic Cryoballoon Ablation System Receives: Procedure: Pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months post-ablation
Secondary outcomes (8)
AF-free survival
Measured: 3, 6 and 12 months post-ablation
Arrhythmia-free survival
Freedom from atrial tachycardia, atrial flutter and AF
Measured: 3, 6 and 12 months post-ablation
Time to first AF recurrence
Measured: 12, 24 and 36 months
Progression from paroxysmal to persistent AF
Measured: 12, 24 and 36 months
Time to first arrhythmia
Measured: 12, 24 and 36 months
Spatial LGE distribution according to local wall thickness (as assessed by preablation CT)
Measured: 3 months post-ablation
Complete pulmonary vein isolation confirmed by persistent entrance- and exit-block
(per-pulmonary vein pair analysis and per-patient analysis
Measured: 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
Measured: periprocedural and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Nov 2023
- Primary completion1 Nov 2025
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivo Roca, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220006
- Sponsor's protocol ID
- PULSED-ICE-CMR
- Acronym
- PULSED-ICE-CMR
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lesion Formation With Pulsed Field Versus Cryobaloon Ablation as Assessed by Cardiac Magnetic Resoncance
- ClinicalTrials.gov ID
- NCT06220006
- Acronym / sponsor ID
- PULSED-ICE-CMR / PULSED-ICE-CMR
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Catheter ablation, Ablation lesion, Pulmonary vein isolation, Pulsed field ablation, Cryoballoon ablation, Cardiac magnetic resonance, Late gadolinium enhancement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Field Ablation | Experimental | Procedure: Pulmonary vein isolationPulmonary vein isolation using the Farapulse Pulsed Field Ablation System (Boston Scientific) |
| Cryoballoon Ablation | Active comparator | Procedure: Pulmonary vein isolationPulmonary vein isolation using the Medtronic Cryoballoon Ablation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for first-time atrial fibrillation catheter ablation
Key exclusion criteria (9 listed)
- age <18 years
- long-standing persistent atrial fibrillation
- prior left atrial ablation
- pregnancy or lactation
- reduced left ventricular ejection fraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary vein isolationCatheter ablation | Procedure or surgery | Cryoballoon Ablation, Pulsed Field Ablation |
Primary outcome
LGE-CMR-determined ablation lesion quality
Time frame: 3 months post-ablation
Complete late gadolinium enhancement encircling both pulmonarz vein pairs, with discontinuations adding up to less than 10% of the total length of the circumference
8 secondary outcomes
AF-free survival
Time frame: 3, 6 and 12 months post-ablation
Arrhythmia-free survival
Time frame: 3, 6 and 12 months post-ablation
Time to first AF recurrence
Time frame: 12, 24 and 36 months
Progression from paroxysmal to persistent AF
Time frame: 12, 24 and 36 months
Time to first arrhythmia
Time frame: 12, 24 and 36 months
Spatial LGE distribution according to local wall thickness (as assessed by preablation CT)
Time frame: 3 months post-ablation
Complete pulmonary vein isolation confirmed by persistent entrance- and exit-block
Time frame: intra-procedural
Safety events
Time frame: periprocedural and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation in people with Atrial Fibrillation, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LGE-CMR-determined ablation lesion quality (time frame: 3 months post-ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.