New study aims to make heart ablation faster and safer
NCT ID NCT05805189
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Maria Cecilia Hospital
Cotignola, Ravenna, 48033, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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