TerminatedNot Applicable

Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation

Stopped: Insufficient enrollment related to ILR coverage barriers and the resulting inability to meet timelines with the available funding.

United States198 participantsStarted 2024-10-08

Plain-language summary

The purpose of this study is to compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF).

Who can participate

Age range

21 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision of signed and dated informed consent form.
. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Age 21-90 years.
. Symptomatic PAF whether failed AAD or not.
. At least one symptomatic episode of PAF lasting \<7 days, documented on electrocardiogram (ECG), Holter, ZioPatch, ILR, or smartwatch recording in the year prior to enrollment.
. Patients undergoing first time ablation for AF.
. Subject has any commercially available implantable loop recorder (ILR) or agrees to have one implanted prior or during the ablation procedure.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Procedural success, defined as freedom from of all documented atrial arrhythmias episodes after the 3-month blanking period.

Timeframe: 12 months

The primary safety endpoint is a composite of acute procedure-related complications and any other major adverse events within the 12 months following the ablation procedure.

Timeframe: 12 Months

Trial details

NCT IDNCT06364215

SponsorJorge Romero

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-16

View on ClinicalTrials.gov More Atrial Fibrillation Paroxysmal trials

Who can participate

Age range

21 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision of signed and dated informed consent form.
. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Age 21-90 years.
. Symptomatic PAF whether failed AAD or not.
. At least one symptomatic episode of PAF lasting \<7 days, documented on electrocardiogram (ECG), Holter, ZioPatch, ILR, or smartwatch recording in the year prior to enrollment.
. Patients undergoing first time ablation for AF.
. Subject has any commercially available implantable loop recorder (ILR) or agrees to have one implanted prior or during the ablation procedure.

What they're measuring

Procedural success, defined as freedom from of all documented atrial arrhythmias episodes after the 3-month blanking period.

Timeframe: 12 months

The primary safety endpoint is a composite of acute procedure-related complications and any other major adverse events within the 12 months following the ablation procedure.

Timeframe: 12 Months

Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria