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New study aims to make heart ablation faster and safer

NCT ID NCT05805189

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at two methods for treating atrial fibrillation (an irregular heartbeat) using a special balloon catheter. The goal is to see if using a 3D mapping system (CARTO) makes the procedure faster and safer than using X-ray guidance alone. About 60 adults with paroxysmal atrial fibrillation will take part, and researchers will track how well the treatment works over one year.

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 60 people

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

Started

Feb 2023

Expected to finish

Sep 2026

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 years and older

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: The following criteria must be met for subjects to be eligible for inclusion into the study * Subjects indicated for the treatment of paroxysmal AF with the RF ablation system according to current and future Guidelines and system indications for use * Subjects who are willing and capable of providing informed consent * Patients who have stopped amiodarone for at least one month * Subjects whose age is \> 18 years old * Subjects whose age is \< 80 years old * Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center Exclusion Criteria: Subjects who meet any one of the following criteria will be excluded from this clinical study * Patients who had already undergo an AF ablation procedure * Any known contraindication to an AF ablation or anticoagulation, including those listed in the instructions for use * Subjects with indication for treatment of AF that is not according to current and future Guidelines and system indications for use * Presence of an intracavitary thrombus * Subjects that are unable or not willing to complete follow-up visits and examination for the duration of the study * Patients with left ventricular ejection fraction \< 35% * Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion) * Hematological contraindications to ionizing radiation exposure * Presence of complex congenital heart disease, and cardiac surgery within 1 month from enrollment * Uncontrolled heart failure * Subjects with severe valvular disease OR with a prosthetic - mechanical or biological- heart valve (not including valve repair and annular rings) * Contraindications to general anesthesia * Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Maria Cecilia Hospital

    Cotignola, Ravenna, 48033, Italy

More trials for these conditions

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