Atrial Fibrillation (AF)PRECLUDENCT07620262
Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study
A study testing Remapping Procedure in people with Atrial Fibrillation (AF), run by Northwell Health at 1 site in United States.
Trial summary
This is a single-arm, open label, clinical outcome study to research the durability (success) of receiving a pulsed field ablation (PFA) per standard of care for treatment of atrial fibrillation during a subsequent procedure for the insertion of a left atrial appendage occlusion (LAAO) device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Remapping Procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to Jul 2028
- 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
- Participant is ≥ 18 years of age, or older if specified by local law
- Participant has documented paroxysmal or persistent atrial fibrillation not related to a reversible cause
- Participant has AF-related symptoms, and/or presence of CHF or LV dysfunction
- Participant has a CHADSVASc>=3 in women and >=2 in men
- There is appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation for thromboembolic protection
- Participant is willing and capable of providing informed consent
- Participant is willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center
Who cannot join
- Participant has had prior AF ablation (including surgical ablation)
- Participant has had prior left atrial appendage occlusion or closure
- Participant has an intracardiac mass or thrombus
- Participant has had a bleeding disorder or inability to tolerate short-term oral anticoagulation
- Participant has a life expectancy < 1 year
- Participant has had recent MI, CVA, or cardiac surgery in preceding 90 days
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- Participant has an inability to comply with outpatient follow-up, or cognitive impairment that precludes understanding of procedure risks and benefits
- Participant has an active systemic infection
- Participant has a mechanical heart valve through which the catheter must pass, or severe mitral stenosis
- Participant has a vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach
- Participant had congenital heart disease where the underlying abnormality increases the risk of ablation (e.g. severe rotational anomalies of the heart or great vessels)
- Participant is woman of childbearing potential who is pregnant, lactating, not using a reliable form of contraception, or who is planning to become pregnant during the anticipated study period
- Participant has longstanding persistent AF ongoing for greater than 10 years
- Participant has Left atrial appendage anatomy unsuitable for LAAO device
- Participant has an LA diameter >6 cm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
South Shore University Hospital
Bay Shore, New York, 11706
Jason Chinitz, MD, 631-968-3016, jchinitz@northwell.edu
Rachel Gentles, 6319683016, rgentles1@northwell.edu
About this study
This is a single-arm, open label, clinical outcome study to research the durability (success) of receiving a pulsed field ablation (PFA) per standard of care for treatment of atrial fibrillation during a subsequent procedure for the insertion of a left atrial appendage occlusion (LAAO) device. The reassessment of the initial ablation will be performed with or without additional ablation if needed.
Read the detailed description
Atrial fibrillation is a heart condition where the heart beats rapidly and/or irregularly. An ablation procedure is a form of treatment for atrial fibrillation to try to maintain or return the heart to a normal rhythm (called sinus rhythm). Ablation procedures can be done using heat (radiofrequency energy), cold (cryo energy), or electrical energy emitted by pulses (pulsed field ablation). Pulsed field ablation (PFA) is an invasive treatment procedure for which the doctor will deliver controlled energy through a PFA Catheter to destroy or scar the specific heart tissue causing the abnormal electrical signals. This scar helps to interrupt the abnormal electrical pathways and restore a normal heart rhythm. Ablation procedures are performed according to the standard of care.
The purpose of this study is to research the durability of receiving a PFA for the treatment of atrial fibrillation during a subsequent procedure performed at least 30 days after the initial ablation. The remapping procedure will utilize integrated electroanatomic mapping and intracardiac echocardiography to determine the index procedure technical success independent of arrhythmia recurrence.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Remapping Procedure
- Keywords
- Ablation, Atrial Fibrilation, Re-mapping, LAAO Device
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remapping ProcedureDevice
Remapping procedure with LAAO Implant with or without additional ablation.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm, open label - all enrolled subjects | Experimental | Remapping procedure with LAAO Implant with or without additional ablation. Receives: Device: Remapping Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
To prospectively assess durability of PFA ablation
Durability analysis will include % of patients with any PV reconnection, % of PVs reconnected, and % of patients with recovered conduction in the endocardial posterior wall (if posterior wall isolation performed at the index procedure).
Measured: From Index Ablation to Subsequent Re-mapping procedure with concomitant LAAO implant. The remapping procedure will occur approximately 30-180 days after the index ablation.
Secondary outcomes (3)
To assess arrhythmia-free survival in patients with confirmed durable PVI (+/-) posterior wall isolation
Patients demonstrating durable PVI (+/- posterior wall isolation) confirmed during remapping procedure will be monitored for arrhythmia recurrence. Arrhythmia recurrence will be evaluated based on 1-week extended Holter monitoring performed at 6 months and 12 months post ablation.
Measured: 6 months and 12 months post remapping procedure
Assess clinical outcomes following strategy of LAAO implant and potential for repeat AF ablation performed as consecutive procedures.
Clinical outcomes following this novel prospective dual-procedure strategy will be analyzed, including assessment of clinical AT/AF recurrence and symptomatic arrhythmia recurrence.
Measured: From enrollment/index ablation to the 12month follow up post remapping procedure
Assess procedure related outcomes following strategy of LAAO implant and potential for repeat AF ablation performed as consecutive procedures.
Procedural related outcomes following this novel prospective dual-procedure strategy will be analyzed, including assessment of ischemic stroke/TIA, bleeding complications, hospitalizations, and death.
Measured: From enrollment/index ablation to the 12month follow up post remapping procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 May 2026
- Primary completionMay 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, open label
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620262
- Sponsor's protocol ID
- 25-1100
- Acronym
- PRECLUDE
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study
- ClinicalTrials.gov ID
- NCT07620262
- Acronym / sponsor ID
- PRECLUDE / 25-1100
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Ablation, Atrial Fibrilation, Re-mapping, LAAO Device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 May 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 2 Jun 2026 (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 is a single-arm, open label, clinical outcome study to research the durability (success) of receiving a pulsed field ablation (PFA) per standard of care for treatment of atrial fibrillation during a subsequent procedure for the insertion of a left atrial appendage occlusion (LAAO) device. The reassessment of the initial ablation will be performed with or without additional ablation if needed.
Detailed description
Atrial fibrillation is a heart condition where the heart beats rapidly and/or irregularly. An ablation procedure is a form of treatment for atrial fibrillation to try to maintain or return the heart to a normal rhythm (called sinus rhythm). Ablation procedures can be done using heat (radiofrequency energy), cold (cryo energy), or electrical energy emitted by pulses (pulsed field ablation). Pulsed field ablation (PFA) is an invasive treatment procedure for which the doctor will deliver controlled energy through a PFA Catheter to destroy or scar the specific heart tissue causing the abnormal electrical signals. This scar helps to interrupt the abnormal electrical pathways and restore a normal heart rhythm. Ablation procedures are performed according to the standard of care.
The purpose of this study is to research the durability of receiving a PFA for the treatment of atrial fibrillation during a subsequent procedure performed at least 30 days after the initial ablation. The remapping procedure will utilize integrated electroanatomic mapping and intracardiac echocardiography to determine the index procedure technical success independent of arrhythmia recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open label
| Arm | Type | Receives |
|---|---|---|
| Single-arm, open label - all enrolled subjects | Experimental | Device: Remapping ProcedureRemapping procedure with LAAO Implant with or without additional ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant is ≥ 18 years of age, or older if specified by local law
- Participant has documented paroxysmal or persistent atrial fibrillation not related to a reversible cause
- Participant has AF-related symptoms, and/or presence of CHF or LV dysfunction
- Participant has a CHADSVASc>=3 in women and >=2 in men
- There is appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation for thromboembolic protection
Key exclusion criteria (15 listed)
- Participant has had prior AF ablation (including surgical ablation)
- Participant has had prior left atrial appendage occlusion or closure
- Participant has an intracardiac mass or thrombus
- Participant has had a bleeding disorder or inability to tolerate short-term oral anticoagulation
- Participant has a life expectancy < 1 year
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 |
|---|---|---|
| Remapping ProcedureRemapping procedure with LAAO Implant with or without additional ablation. | Device | Single-arm, open label - all enrolled subjects |
Primary outcome
To prospectively assess durability of PFA ablation
Time frame: From Index Ablation to Subsequent Re-mapping procedure with concomitant LAAO implant. The remapping procedure will occur approximately 30-180 days after the index ablation.
Durability analysis will include % of patients with any PV reconnection, % of PVs reconnected, and % of patients with recovered conduction in the endocardial posterior wall (if posterior wall isolation performed at the index procedure).
3 secondary outcomes
To assess arrhythmia-free survival in patients with confirmed durable PVI (+/-) posterior wall isolation
Time frame: 6 months and 12 months post remapping procedure
Assess clinical outcomes following strategy of LAAO implant and potential for repeat AF ablation performed as consecutive procedures.
Time frame: From enrollment/index ablation to the 12month follow up post remapping procedure
Assess procedure related outcomes following strategy of LAAO implant and potential for repeat AF ablation performed as consecutive procedures.
Time frame: From enrollment/index ablation to the 12month follow up post remapping procedure
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remapping Procedure in people with Atrial Fibrillation (AF), run by Northwell Health at 1 site in United States.
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 7 inclusion and 15 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 13 Oct 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 United States. 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?
To prospectively assess durability of PFA ablation (time frame: From Index Ablation to Subsequent Re-mapping procedure with concomitant LAAO implant. The remapping procedure will occur approximately 30-180 days after the index 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 13 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.