Atrial FibrillationEASy-PULSE AFNCT06351553
Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation
A study testing Pulmonary vein isolation exclusively with radiofrequency, Pulmonary vein isolation exclusively with pulsed field ablation and Combined pulmonary vein isolation in people with Atrial Fibrillation, run by Hospital General Universitario de Alicante at 1 site in Spain.
Trial summary
Pulmonary vein (PV) isolation is considered the therapeutic strategy of choice to maintain sinus rhythm (SR) in symptomatic patients with atrial fibrillation (AF). The most commonly used energy modality is radiofrequency (RF). 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 exclusively with radiofrequency, Pulmonary vein isolation exclusively with pulsed field ablation and Combined pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 with a diagnosis of paroxysmal atrial fibrillation, referred to our center for pulmonary vein isolation, who are willing and able to sign the informed consent.
Who cannot join
- Patients with permanent atrial fibrillation.
- Patients with previous pulmonary vein isolation procedure.
- Patients with pacemakers, or with a diagnosis of atrioventricular block or sinus dysfunction.
- Patients who show their refusal to participate in the registry, or are unable to understand the informed consent.
- Patients under 18 years of age.
- Pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation (EASy-PULSE AF)
Pulmonary vein (PV) isolation is considered the therapeutic strategy of choice to maintain sinus rhythm (SR) in symptomatic patients with atrial fibrillation (AF). The most commonly used energy modality is radiofrequency (RF). However, this type of energy presents notable challenges, such as its lack of selectivity for myocardial tissue, which increases the risk of serious complications such as atrioesophageal fistula, PV stenosis, and vagus nerve injuries. In this context, PV isolation using pulsed field ablation (PFA) emerges as a promising alternative due to its greater myocardial selectivity. However, this selectivity presents additional challenges. Preliminary studies indicate that PFA may not damage the autonomic nervous system (ANS) involved in the initiation and maintenance of AF in certain patients, although stronger evidence is needed to support this claim.
The investigators propose to carry out a single-center clinical trial, although with the possibility in the future of including other centers. Patients will be randomized to three research groups: PV isolation with RF, PV isolation with PFA, and PV isolation combining PFA and RF (using RF on the anterior wall and PFA on the posterior wall). This assignment will be open to the operator who performs the procedure, but blind for the researcher responsible for monitoring and for the data analyst. The objective is to compare the impact of different energy sources during PV isolation on the ability to produce a permanent alteration in the ANS. The hypothesis is that combined PF isolation will be capable of producing a permanent alteration of autonomic function parameters superior to ablation using exclusive PFA.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulmonary vein isolation exclusively with radiofrequency, Pulmonary vein isolation exclusively with pulsed field ablation, Combined pulmonary vein isolation
- Keywords
- Atrial Fibrillation, Pulmonary Vein Isolation, Pulsed Field 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.
Pulmonary vein isolation exclusively with radiofrequencyProcedure or surgery
The QDOT (Biosense Webster, Inc.) or TactiFlex (Abbott S.E.) catheters will be used. The ablation will be controlled by temperature, with a limit of 42ºC and a power target of 30-40W. A high-power strategy (90 W/4 seconds) can be used on the posterior wall when the QDOT catheter is used.
Pulmonary vein isolation exclusively with pulsed field ablationProcedure or surgery
The Sphere-9 catheter will be used (with biphasic and unipolar wave), with a duration per application of 5 seconds and a separation between lesions of 5-6mm. The target temperature increase will be at least 1.5ºC above the patient's basal temperature to mark the ablation as effective.
Combined pulmonary vein isolationProcedure or surgery
The Sphere-9 catheter will be used for both radiofrequency and pulsed field ablation. When using radiofrequency, the ablation will be temperature controlled, with a target temperature of 73ºC. The duration per application will be 5 seconds. Catheter irrigation during ablation will be 30ml/min, with a maximum current intensity of 3700mA, and a maximum current density of 13.6mA/mm2. The separation between lesions will be 7-8mm. Regarding pulsed field ablation, the characteristics will be those indicated in "Pulmonary vein isolation exclusively with pulsed field ablation" group.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary vein isolation exclusively with radiofrequency | Active comparator | The ablation of the anterior and posterior wall will be performed with radiofrequency. Receives: Procedure: Pulmonary vein isolation exclusively with radiofrequency |
| Pulmonary vein isolation exclusively with pulsed field ablation | Experimental | The ablation of the anterior and posterior wall will be performed with pulsed field ablation. Receives: Procedure: Pulmonary vein isolation exclusively with pulsed field ablation |
| Combined pulmonary vein isolation | Experimental | The ablation of the anterior wall will be performed with radiofrequency, and the posterior wall with pulsed field ablation. Receives: Procedure: Combined pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy primary outcome: Alteration of autonomic function parameters
Determine if combined pulmonary vein isolation (anterior wall ablation with radiofrequency and posterior wall ablation with pulsed field ablation) will be capable of producing a permanent alteration of autonomic function parameters (average heart rate) greater than exclusive pulsed field ablation.
Measured: Two years
Secondary outcomes (4)
Efficacy secondary outcome: Alteration of autonomic function parameters
Determine if combined pulmonary vein isolation (anterior wall ablation with radiofrequency and posterior wall ablation with pulsed field ablation) will be capable of producing a permanent alteration of autonomic function parameters (attenuation of heart rate variability) greater than exclusive pulsed field ablation.
Measured: Two years
Efficacy secondary outcome: Alteration of autonomic function parameters
Determine if combined pulmonary vein isolation (anterior wall ablation with radiofrequency and posterior wall ablation with pulsed field ablation) is at least as effective as exclusive radiofrequency pulmonary vein isolation in its ability to produce a permanent alteration of autonomic function parameters (average heart rate).
Measured: Two years
Efficacy secondary outcome: Alteration of autonomic function parameters
Determine if combined pulmonary vein isolation (anterior wall ablation with radiofrequency and posterior wall ablation with pulsed field ablation) is at least as effective as exclusive radiofrequency pulmonary vein isolation in its ability to produce a permanent alteration of autonomic function parameters (attenuation of heart rate variability).
Measured: Two years
Efficacy secondary outcome: Procedure duration.
Determine if combined pulmonary vein isolation or exclusive pulmonary vein isolation with pulsed field ablation will shorten procedure times compared to exclusive radiofrequency pulmonary vein isolation.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Luis Ibañez Criado, Hospital General Universitario de Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351553
- Sponsor's protocol ID
- 2023-169
- Acronym
- EASy-PULSE AF
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation (EASy-PULSE AF)
- ClinicalTrials.gov ID
- NCT06351553
- Acronym / sponsor ID
- EASy-PULSE AF / 2023-169
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Pulmonary Vein Isolation, Pulsed Field Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Hospital General Universitario de AlicanteUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 8 Apr 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.
Pulmonary vein (PV) isolation is considered the therapeutic strategy of choice to maintain sinus rhythm (SR) in symptomatic patients with atrial fibrillation (AF). The most commonly used energy modality is radiofrequency (RF). However, this type of energy presents notable challenges, such as its lack of selectivity for myocardial tissue, which increases the risk of serious complications such as atrioesophageal fistula, PV stenosis, and vagus nerve injuries. In this context, PV isolation using pulsed field ablation (PFA) emerges as a promising alternative due to its greater myocardial selectivity. However, this selectivity presents additional challenges. Preliminary studies indicate that PFA may not damage the autonomic nervous system (ANS) involved in the initiation and maintenance of AF in certain patients, although stronger evidence is needed to support this claim.
The investigators propose to carry out a single-center clinical trial, although with the possibility in the future of including other centers. Patients will be randomized to three research groups: PV isolation with RF, PV isolation with PFA, and PV isolation combining PFA and RF (using RF on the anterior wall and PFA on the posterior wall). This assignment will be open to the operator who performs the procedure, but blind for the researcher responsible for monitoring and for the data analyst. The objective is to compare the impact of different energy sources during PV isolation on the ability to produce a permanent alteration in the ANS. The hypothesis is that combined PF isolation will be capable of producing a permanent alteration of autonomic function parameters superior to ablation using exclusive PFA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulmonary vein isolation exclusively with radiofrequency | Active comparator | Procedure: Pulmonary vein isolation exclusively with radiofrequencyThe ablation of the anterior and posterior wall will be performed with radiofrequency. |
| Pulmonary vein isolation exclusively with pulsed field ablation | Experimental | Procedure: Pulmonary vein isolation exclusively with pulsed field ablationThe ablation of the anterior and posterior wall will be performed with pulsed field ablation. |
| Combined pulmonary vein isolation | Experimental | Procedure: Combined pulmonary vein isolationThe ablation of the anterior wall will be performed with radiofrequency, and the posterior wall with pulsed field ablation. |
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 with a diagnosis of paroxysmal atrial fibrillation, referred to our center for pulmonary vein isolation, who are willing and able to sign the informed consent.
Key exclusion criteria (6 listed)
- Patients with permanent atrial fibrillation.
- Patients with previous pulmonary vein isolation procedure.
- Patients with pacemakers, or with a diagnosis of atrioventricular block or sinus dysfunction.
- Patients who show their refusal to participate in the registry, or are unable to understand the informed consent.
- Patients under 18 years of age.
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 isolation exclusively with radiofrequencyThe QDOT (Biosense Webster, Inc.) or TactiFlex (Abbott S.E.) catheters will be used. The ablation will be controlled by temperature, with a limit of 42ºC and a power target of 30-40W. A high-power strategy (90 W/4 seconds) can be used on the posterior wall when the QDOT catheter is used. | Procedure or surgery | Pulmonary vein isolation exclusively with radiofrequency |
| Pulmonary vein isolation exclusively with pulsed field ablationThe Sphere-9 catheter will be used (with biphasic and unipolar wave), with a duration per application of 5 seconds and a separation between lesions of 5-6mm. The target temperature increase will be at least 1.5ºC above the patient's basal temperature to mark the ablation as effective. | Procedure or surgery | Pulmonary vein isolation exclusively with pulsed field ablation |
| Combined pulmonary vein isolationThe Sphere-9 catheter will be used for both radiofrequency and pulsed field ablation. When using radiofrequency, the ablation will be temperature controlled, with a target temperature of 73ºC. The duration per application will be 5 seconds. Catheter irrigation during ablation will be 30ml/min, with a maximum current intensity of 3700mA, and a maximum current density of 13.6mA/mm2. The separation between lesions will be 7-8mm. Regarding pulsed field ablation, the characteristics will be those indicated in "Pulmonary vein isolation exclusively with pulsed field ablation" group. | Procedure or surgery | Combined pulmonary vein isolation |
Primary outcome
Efficacy primary outcome: Alteration of autonomic function parameters
Time frame: Two years
Determine if combined pulmonary vein isolation (anterior wall ablation with radiofrequency and posterior wall ablation with pulsed field ablation) will be capable of producing a permanent alteration of autonomic function parameters (average heart rate) greater than exclusive pulsed field ablation.
4 secondary outcomes
Efficacy secondary outcome: Alteration of autonomic function parameters
Time frame: Two years
Efficacy secondary outcome: Alteration of autonomic function parameters
Time frame: Two years
Efficacy secondary outcome: Alteration of autonomic function parameters
Time frame: Two years
Efficacy secondary outcome: Procedure duration.
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 exclusively with radiofrequency, Pulmonary vein isolation exclusively with pulsed field ablation and Combined pulmonary vein isolation in people with Atrial Fibrillation, run by Hospital General Universitario de Alicante 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 6 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: status not confirmed, as of the sponsor's last update on 8 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy primary outcome: Alteration of autonomic function parameters (time frame: Two years). 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 8 Apr 2024.