Electroanatomical Mapping Versus Fluoroscopy Based Pulmonary Vein Isolation by Means of PulseSelect Catheter in Patients With Atrial Fibrillation

Launched by TSIACHRIS DIMITRIOS · Jun 14, 2025

Keywords

ClinConnect Summary

This clinical trial is comparing two ways of treating a heart rhythm problem called atrial fibrillation (AF) using a procedure called pulmonary vein isolation (PVI). One method uses a special mapping system called electroanatomical mapping (EAM) along with a device called the PulseSelect catheter, while the other uses traditional X-ray guidance (fluoroscopy). Both methods aim to stop the abnormal heart signals causing AF. The study will look at how well each method works both right after the procedure and after about two months.

People who may join this study are adults between 18 and 80 years old who have AF and need PVI treatment for their condition. To participate, patients must agree to the procedure and follow-up visits. The study does not include people who have had previous AF ablations, have very weak heart pumping function, recent heart surgery or stroke, or cannot take blood-thinning medications. Participants can expect to undergo the procedure under deep sedation (a type of strong relaxation medicine) and will be monitored closely during and after to see how well the treatment works. This study is currently looking for volunteers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * ALL the following criteria must be fulfilled:
• • 1. Male or female patients aged ≥18 and \<80 years old.
• • 2. Patients with paroxysmal or persistent AF requiring PVI.
• • 3. Signed written informed consent by the patient for participation in the study and agreement to comply with the procedure and the follow-up schedule
• Exclusion Criteria:
• • 1. Patients with previous AF ablations
• • 2. EF\<35%, CABG surgery within previous 3 months, TIA or stroke within previous 6 months
• • 3. Patients were excluded if ineligible for treatment with oral anticoagulation.