Atrial FibrillationENABLE-CMRNCT05432024
Evaluation of Ablation Lesions Using Cardiovascular Magnetic Resonance Imaging
An observational study of Atrial Fibrillation, run by R&D Cardiologie at 1 site in Netherlands.
Trial summary
Ineffective ablation lesions can cause arrhythmia recurrence after catheter ablation for cardiac arrhythmia. Ablation lesions can be created with various ablation energy modalities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Catheter ablation
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Mar 2023to 1 Apr 2028
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The studied population will be drawn from all patients that are scheduled for catheter ablation at the participating center.
Who may be able to join
- Adult patients (age ≥18 years old)
- Paroxysmal or persistent atrial fibrillation, meeting criteria of the 2020 European Society of Cardiology Guidelines for diagnosis and management of atrial fibrillation
- Patients scheduled to undergo catheter ablation for cardiac arrhythmia using one of the following techniques: Radiofrequency ablation (High power, short duration), Ultra-low temperature cryo ablation, or Pulsed field ablation
Who cannot join
- Known (or suspected) allergic reaction to gadolinium
- Contraindications for MRI (such as claustrophobia, certain implants, devices, high body mass index).
- Pregnancy or breastfeeding
- Prior intervention in the left atrium (ablation or surgery)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
St. Antonius Hospital
Nieuwegein, 3435 CM
Bob GS Abeln, MD, 0883201212 ext. +31, b.abeln@antoniusziekenhuis.nl
Lucas VA Boersma, MD, PhD
About this study
Ineffective ablation lesions can cause arrhythmia recurrence after catheter ablation for cardiac arrhythmia. Ablation lesions can be created with various ablation energy modalities. This study uses cardiovascular magnetic resonance imaging to evaluate the ablation lesion characteristics of radiofrequency ablation, ultra-low temperature cryo ablation, and pulsed field ablation. The ablation lesion characteristics of different energy characteristics will be compared. Additionally, arrhythmia recurrence and quality of life will be evaluated for the different energy modalities.
Read the detailed description
Catheter ablation has become a cornerstone in the treatment of atrial fibrillation (AF). Typically, radiofrequency ablation (RFA) and cryoballoon ablation are used to perform pulmonary vein isolation (PVI). This treatment is effective in the majority of patients, but nevertheless 35% of patients have arrhythmia recurrence at 1-year follow up. These recurrence rates have been attributed to multiple factors, including ineffective ablation lesions, presence of non-pulmonary vein arrhythmia triggers, and disease progression.
Ineffective ablation lesions can cause arrhythmia recurrence through electrical reconnection. Electrical reconnection can occur when gaps are present in the ablation line due to non-durable, non-transmural or non-contiguous ablation lesions. Conventionally, ablation lesion assessment is performed using a redo electrophysiology study at three months post-ablation. During a redo electrophysiology study, a catheter is used to measure the local electrical signals to enable identification of sites with electrical reconnection. This method is effective but poses the patient to the procedural risks of these invasive measurements. Cardiovascular magnetic resonance (CMR) imaging may provide an alternative method for the evaluation of ablation lesions. Modern acquisition and post-processing techniques are under development and being used to image the atrial wall. These techniques may effectively visualize the fibrous tissue of ablation lesions, which enables a non-invasive method to characterize the lesions of catheter ablation.
To reduce arrhythmia recurrence caused by electrical reconnection, several novel ablation techniques have been developed in the last years. These novel ablation techniques can potentially reduce arrhythmia recurrence by enabling the creation of durable, transmural and contiguous ablation lesions. Novel ablation modalities include ultra-low temperature cryoablation (ULTC) and pulsed field ablation (PFA) that use near-critical nitrogen and pulsed electrical fields to create ablation lesions. The initial clinical outcomes of both ablation modalities are favorable, but little data are available on the ablation lesion characteristics. Additionally, novel techniques were developed to improve the procedural outcomes of RFA. High power, short duration (HPSD) RF energy applications cause more resistive and less conductive tissue heating compared to convention RFA, which results in more durable ablation lesions and less arrhythmia recurrence while safety outcomes are similar.
This study aims to use CMR to evaluate the ablation lesion characteristics of HPSD RFA, ULTC and PFA. This novel information can be used to quantitatively compare different ablation modalities. Furthermore, this study could contribute to our knowledge on ablation lesion formation, which may be used to further develop our ablation strategies.
- Conditions
- Atrial Fibrillation
- Being tested
- Catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationDevice
An ablation catheter is introduced in the heart. Ablation is performed by applying ablation energy to the target tissue. The aim of ablation is to create an ablation lesion that does not conduct the electrical signals that induce or sustain the cardiac arrhythmia.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation, High power, short duration | Radiofrequency ablation is an ablation modality that uses radiofrequency energy to create ablation lesions through heat. Patients that are scheduled for pulmonary vein isolation using radiofrequency ablation will be consented for study participation. Receives: Device: Catheter ablation | |
| Ultra-low temperature cryo ablation | Ultra-low temperature cryo ablation is an ablation modality that uses nitrogen near its liquid-vapor critical point to create ablation lesions through ultra-low temperatures. Patients that are scheduled for pulmonary vein isolation using ultra-low temperature cryo ablation will be consented for study participation. Receives: Device: Catheter ablation | |
| Pulsed field ablation | Pulsed field ablation is an ablation modality that uses short lived electrical fields to create ablation lesions through irreversible electroporation. Patients that are scheduled for pulmonary vein isolation using pulsed field ablation will be consented for study participation. Receives: Device: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of gaps in the ablation lesions
Cardiovascular magnetic resonance imaging is used to visualize the ablation lesion. If gaps are present in the ablation lesion, the length of the gaps is measured in millimeter.
Measured: At 3 months follow up
Secondary outcomes (5)
Number of gaps in the ablation lesion
Cardiovascular magnetic resonance imaging is used to visualize the ablation lesion. The number of gaps in the ablation lesion are counted.
Measured: At 3 months follow up
Location of gaps in the ablation lesion
Cardiovascular magnetic resonance imaging is used to visualize the ablation lesion. If gaps are present in the ablation lesion, the location of the gaps is recorded.
Measured: At 3 months follow up
Recurrence of atrial arrhythmia
Ambulatory rhythm monitoring will be performed at 3 and 12 months follow up to assess for recurrences of atrial arrhythmia (i.e. atrial fibrillation, atrial flutter, atrial tachycardia). Additionally, planned and symptom-driven electrocardiograms are assessed for atrial arrhythmia.
Measured: Until 1 year of follow up
Atrial arrhythmia burden
Ambulatory rhythm monitoring will be performed at baseline, 3 and 12 months follow up to assess the atrial arrhythmia (i.e. atrial fibrillation, atrial flutter, atrial tachycardia) burden (proportion of time in atrial arrhythmia).
Measured: Baseline, 3 and 12 months follow up
Atrial fibrillation related quality of life
A validated questionnaire (AFEQT) will be used to evaluate the atrial fibrillation related quality of life at baseline, 3 and 12 months follow up.
Measured: Baseline, 3 and 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start8 Mar 2023
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- R&D Cardiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, L.V.A. Boersma, R&D Cardiologie
- Investigators
- Lucas VA Boersma, MD, PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432024
- Sponsor's protocol ID
- RDC-2022.01
- Acronym
- ENABLE-CMR
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2022
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ablation Lesions Using Cardiovascular Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT05432024
- Acronym / sponsor ID
- ENABLE-CMR / RDC-2022.01
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- R&D CardiologieUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 27 Jun 2022 (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.
Ineffective ablation lesions can cause arrhythmia recurrence after catheter ablation for cardiac arrhythmia. Ablation lesions can be created with various ablation energy modalities. This study uses cardiovascular magnetic resonance imaging to evaluate the ablation lesion characteristics of radiofrequency ablation, ultra-low temperature cryo ablation, and pulsed field ablation. The ablation lesion characteristics of different energy characteristics will be compared. Additionally, arrhythmia recurrence and quality of life will be evaluated for the different energy modalities.
Detailed description
Catheter ablation has become a cornerstone in the treatment of atrial fibrillation (AF). Typically, radiofrequency ablation (RFA) and cryoballoon ablation are used to perform pulmonary vein isolation (PVI). This treatment is effective in the majority of patients, but nevertheless 35% of patients have arrhythmia recurrence at 1-year follow up. These recurrence rates have been attributed to multiple factors, including ineffective ablation lesions, presence of non-pulmonary vein arrhythmia triggers, and disease progression.
Ineffective ablation lesions can cause arrhythmia recurrence through electrical reconnection. Electrical reconnection can occur when gaps are present in the ablation line due to non-durable, non-transmural or non-contiguous ablation lesions. Conventionally, ablation lesion assessment is performed using a redo electrophysiology study at three months post-ablation. During a redo electrophysiology study, a catheter is used to measure the local electrical signals to enable identification of sites with electrical reconnection. This method is effective but poses the patient to the procedural risks of these invasive measurements. Cardiovascular magnetic resonance (CMR) imaging may provide an alternative method for the evaluation of ablation lesions. Modern acquisition and post-processing techniques are under development and being used to image the atrial wall. These techniques may effectively visualize the fibrous tissue of ablation lesions, which enables a non-invasive method to characterize the lesions of catheter ablation.
To reduce arrhythmia recurrence caused by electrical reconnection, several novel ablation techniques have been developed in the last years. These novel ablation techniques can potentially reduce arrhythmia recurrence by enabling the creation of durable, transmural and contiguous ablation lesions. Novel ablation modalities include ultra-low temperature cryoablation (ULTC) and pulsed field ablation (PFA) that use near-critical nitrogen and pulsed electrical fields to create ablation lesions. The initial clinical outcomes of both ablation modalities are favorable, but little data are available on the ablation lesion characteristics. Additionally, novel techniques were developed to improve the procedural outcomes of RFA. High power, short duration (HPSD) RF energy applications cause more resistive and less conductive tissue heating compared to convention RFA, which results in more durable ablation lesions and less arrhythmia recurrence while safety outcomes are similar.
This study aims to use CMR to evaluate the ablation lesion characteristics of HPSD RFA, ULTC and PFA. This novel information can be used to quantitatively compare different ablation modalities. Furthermore, this study could contribute to our knowledge on ablation lesion formation, which may be used to further develop our ablation strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation, High power, short duration | – | Device: Catheter ablationRadiofrequency ablation is an ablation modality that uses radiofrequency energy to create ablation lesions through heat. Patients that are scheduled for pulmonary vein isolation using radiofrequency ablation will be consented for study participation. |
| Ultra-low temperature cryo ablation | – | Device: Catheter ablationUltra-low temperature cryo ablation is an ablation modality that uses nitrogen near its liquid-vapor critical point to create ablation lesions through ultra-low temperatures. Patients that are scheduled for pulmonary vein isolation using ultra-low temperature cryo ablation will be consented for study participation. |
| Pulsed field ablation | – | Device: Catheter ablationPulsed field ablation is an ablation modality that uses short lived electrical fields to create ablation lesions through irreversible electroporation. Patients that are scheduled for pulmonary vein isolation using pulsed field ablation will be consented for study participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The studied population will be drawn from all patients that are scheduled for catheter ablation at the participating center.
Key inclusion criteria (3 listed)
- Adult patients (age ≥18 years old)
- Paroxysmal or persistent atrial fibrillation, meeting criteria of the 2020 European Society of Cardiology Guidelines for diagnosis and management of atrial fibrillation
- Patients scheduled to undergo catheter ablation for cardiac arrhythmia using one of the following techniques: Radiofrequency ablation (High power, short duration), Ultra-low temperature cryo ablation, or Pulsed field ablation
Key exclusion criteria (4 listed)
- Known (or suspected) allergic reaction to gadolinium
- Contraindications for MRI (such as claustrophobia, certain implants, devices, high body mass index).
- Pregnancy or breastfeeding
- Prior intervention in the left atrium (ablation or surgery)
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 |
|---|---|---|
| Catheter ablationAn ablation catheter is introduced in the heart. Ablation is performed by applying ablation energy to the target tissue. The aim of ablation is to create an ablation lesion that does not conduct the electrical signals that induce or sustain the cardiac arrhythmia. | Device | Pulsed field ablation, Radiofrequency ablation, High power, short duration, Ultra-low temperature cryo ablation |
Primary outcome
Length of gaps in the ablation lesions
Time frame: At 3 months follow up
Cardiovascular magnetic resonance imaging is used to visualize the ablation lesion. If gaps are present in the ablation lesion, the length of the gaps is measured in millimeter.
5 secondary outcomes
Number of gaps in the ablation lesion
Time frame: At 3 months follow up
Location of gaps in the ablation lesion
Time frame: At 3 months follow up
Recurrence of atrial arrhythmia
Time frame: Until 1 year of follow up
Atrial arrhythmia burden
Time frame: Baseline, 3 and 12 months follow up
Atrial fibrillation related quality of life
Time frame: Baseline, 3 and 12 months follow up
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 28 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Lucas VA Boersma, MD, PhD principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by R&D Cardiologie at 1 site in Netherlands.
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 3 inclusion and 4 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 28 Jul 2025. 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 Netherlands. 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?
Contact Lucas VA Boersma, MD, PhD (0883200900 ext. +31, l.boersma@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of gaps in the ablation lesions (time frame: At 3 months follow up). 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 28 Jul 2025.