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More zaps, better rhythm? trial tests extra ablations for AFib

NCT ID NCT07021313

Disease control Sponsor: R&D Cardiologie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This trial compares standard versus extra pulsed field ablation applications during pulmonary vein isolation in people with atrial fibrillation. The goal is to see if more targeted ablations improve freedom from irregular heart rhythms for up to 18 months. Participants are adults with paroxysmal or persistent AFib scheduled for catheter ablation with the FARAPULSE system.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pulsed field ablation (FARAPULSE system)
What this could lead to
If successful, this approach could make atrial fibrillation ablation more durable, reducing the need for repeat procedures.
What could go wrong
This is an early-stage comparison of application numbers; the extra applications may not improve outcomes and could increase risks like tamponade or stroke.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 378 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Be scheduled for PVI with the use of the FARAPULSE catheter ablation system AND * Have paroxysmal atrial fibrillation (PAF) documented in the last 6 months prior to enrolment OR * Had persistent atrial fibrillation but maintained in SR or converted to paroxysmal by antiarrhythmic drugs with no more than 1 cardioversion beyond 7 days in the past Exclusion Criteria: * Cerebrovascular accident (CVA) in the last 6 months * More than moderate valvular disease that would require intervention * Cardiac catheter/surgical intervention in the last 3 months or scheduled * Atrial septal defect (ASD)/ patent foramen ovale (PFO) closure in the past * Left atrial appendage (LAA) closure in the past * Mechanical mitral valve * Non-adherence to oral anticoagulation in the 3 weeks prior to ablation * Renal disease with known eGFR\<45 ml * Left atrial volume index (LAVI) \>50 ml/m2 or left atrial diameter (LAD) \>50 mm * Known contra-indication for catheter ablation * Known contra-indication for deep sedation or general anesthesia * Known pregnancy

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation

Contacts and locations

Locations

  • St. Antonius Hospital

    Nieuwegein, 3435 CM, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.